Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia (SPIRE-FH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01968980
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : May 19, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heterozygous Familial Hypercholesterolemia
Interventions Drug: Bococizumab (PF-04950615;RN316)
Other: Placebo
Enrollment 370
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Period Title: Overall Study
Started 185 185
Completed 169 171
Not Completed 16 14
Reason Not Completed
Death             0             1
Adverse Event             1             3
Does not meet entry criteria             1             3
Withdrawal by Subject             13             5
Other unspecified             1             2
Arm/Group Title Placebo PF­-04950615 Total
Hide Arm/Group Description Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Total of all reporting groups
Overall Number of Baseline Participants 185 185 370
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 185 participants 370 participants
55.7  (11.2) 56.5  (10.5) 56.1  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 185 participants 370 participants
Female
82
  44.3%
73
  39.5%
155
  41.9%
Male
103
  55.7%
112
  60.5%
215
  58.1%
1.Primary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 175 166
Mean (Standard Deviation)
Unit of Measure: percent change
-0.3  (18.30) -54.2  (29.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -54.5
Confidence Interval (2-Sided) 95%
-59.5 to -49.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.54
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 175 166
Mean (Standard Deviation)
Unit of Measure: percent change
-0.0  (14.45) -37.0  (19.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.6
Confidence Interval (2-Sided) 95%
-41.1 to -34.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.77
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 175 166
Mean (Standard Deviation)
Unit of Measure: percent change
0.4  (17.89) -49.9  (26.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -51.0
Confidence Interval (2-Sided) 95%
-55.7 to -46.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 175 166
Mean (Standard Deviation)
Unit of Measure: percent change
0.4  (15.96) -47.5  (28.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -48.0
Confidence Interval (2-Sided) 95%
-52.8 to -43.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.44
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 172 166
Mean (Standard Deviation)
Unit of Measure: percent change
2.2  (27.21) -26.4  (23.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -28.6
Confidence Interval (2-Sided) 95%
-33.9 to -23.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.73
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 175 166
Mean (Standard Deviation)
Unit of Measure: percent change
-0.3  (12.99) 6.3  (15.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
4.1 to 9.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.47
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =175, 173) 2.7  (25.38) -50.1  (32.94)
Week 52 (n =169, 171) 3.5  (21.49) -45.3  (30.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -52.1
Confidence Interval (2-Sided) 95%
-58.2 to -46.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -48.0
Confidence Interval (2-Sided) 95%
-53.6 to -42.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.87
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =176, 173) 1.6  (19.10) -34.4  (21.44)
Week 52 (n =169, 171) 1.2  (15.82) -31.0  (21.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -35.8
Confidence Interval (2-Sided) 95%
-40.0 to -31.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -31.8
Confidence Interval (2-Sided) 95%
-35.8 to -27.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.02
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =174, 173) 2.4  (24.06) -46.7  (29.88)
Week 52 (n =169, 171) 1.2  (19.25) -41.8  (29.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -48.5
Confidence Interval (2-Sided) 95%
-54.1 to -42.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -42.2
Confidence Interval (2-Sided) 95%
-47.5 to -36.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =176, 171) 2.6  (19.29) -44.8  (30.40)
Week 52 (n =169, 171) 1.7  (16.45) -39.3  (28.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -46.8
Confidence Interval (2-Sided) 95%
-52.1 to -41.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -40.5
Confidence Interval (2-Sided) 95%
-45.5 to -35.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.53
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =175, 172) 14.6  (157.93) -21.2  (48.77)
Week 52 (n =168, 171) 1.3  (30.50) -15.1  (68.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -35.1
Confidence Interval (2-Sided) 95%
-59.8 to -10.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.3
Confidence Interval (2-Sided) 95%
-26.3 to -4.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.58
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 24 (n =174, 173) 0.9  (14.19) 6.6  (12.85)
Week 52 (n =169, 171) 2.2  (14.51) 4.7  (14.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.9
Confidence Interval (2-Sided) 95%
3.1 to 8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-0.1 to 5.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.53
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =175, 166) 7.1  (41.23) -8.7  (38.07)
Week 24 (n =176, 173) 7.6  (51.97) -9.0  (40.01)
Week 52 (n =169, 171) 4.9  (33.03) -3.4  (58.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.0
Confidence Interval (2-Sided) 95%
-25.3 to -8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.4
Confidence Interval (2-Sided) 95%
-27.0 to -7.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.5
Confidence Interval (2-Sided) 95%
-19.4 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.04
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =175, 166) -0.5  (11.70) 4.8  (12.15)
Week 24 (n =176, 172) -0.6  (10.69) 3.9  (10.72)
Week 52 (n =169, 171) 0.3  (12.02) 3.0  (11.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
2.9 to 7.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
2.5 to 6.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.5 to 5.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.22
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =175, 166) -2.6  (13.34) -1.6  (15.68)
Week 24 (n =175, 170) -2.8  (11.88) -1.8  (13.45)
Week 52 (n =167, 171) -3.5  (11.90) -2.4  (14.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.3 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.9 to 3.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-1.9 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 (n =175, 166) 7.1  (41.23) -8.7  (38.07)
Week 24 (n =176, 173) 7.6  (51.97) -9.0  (40.01)
Week 52 (n =169, 171) 4.9  (33.03) -3.4  (58.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.0
Confidence Interval (2-Sided) 95%
-25.3 to -8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.4
Confidence Interval (2-Sided) 95%
-27.0 to -7.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.5
Confidence Interval (2-Sided) 95%
-19.4 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.04
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n= 185, 185) 150.0  (59.75) 144.2  (41.96)
Change at Week 12 (n= 175, 166) -3.0  (30.47) -79.1  (46.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -78.8
Confidence Interval (2-Sided) 95%
-86.2 to -71.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.75
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 185, 185) 227.2  (67.31) 220.7  (46.26)
Change at Week 12 (n= 175, 166) -2.8  (36.43) -83.2  (49.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -83.2
Confidence Interval (2-Sided) 95%
-91.3 to -75.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.15
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 185, 185) 178.6  (66.64) 170.4  (45.12)
Change at Week 12 (n= 175, 166) -2.3  (36.24) -86.0  (51.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -87.0
Confidence Interval (2-Sided) 95%
-95.4 to -78.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.25
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 185, 185) 115.9  (35.25) 112.8  (26.26)
Change at Week 12 (n= 175, 166) -0.9  (20.51) -53.7  (33.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -53.8
Confidence Interval (2-Sided) 95%
-59.2 to -48.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Absolute Change From Baseline in Lipoprotein (a) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 184, 185) 58.8  (69.88) 59.7  (63.38)
Change at Week 12 (n= 172, 166) -1.4  (14.02) -14.0  (17.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-14.7 to -8.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.47
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 185, 185) 48.6  (11.84) 50.3  (11.40)
Change at Week 12 (n= 175, 166) -0.6  (6.31) 2.8  (7.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
2.0 to 4.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n =185, 185) 4.9  (1.81) 4.6  (1.32)
Change at Week 12 (n =175, 166) 0.0  (1.00) -1.8  (1.29)
Change at Week 24 (n =174, 173) 0.0  (1.20) -1.7  (1.29)
Change at Week 52 (n =169, 171) -0.0  (1.00) -1.5  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-2.2 to -1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.1 to -1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-1.8 to -1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Baseline, Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n =185, 185) 0.8  (0.31) 0.8  (0.23)
Change at Week 12 (n =175, 166) 0.0  (0.18) -0.4  (0.25)
Change at Week 24 (n =176, 171) 0.0  (0.17) -0.4  (0.25)
Change at Week 52 (n =169, 171) 0.0  (0.17) -0.3  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.5 to -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.4 to -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n =175, 166) 13.1 83.1
Week 24 (n =175, 173) 13.1 80.9
Week 52 (n =169, 171) 16.6 70.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 51.8
Confidence Interval (2-Sided) 95%
25.24 to 106.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 66.9
Confidence Interval (2-Sided) 95%
30.32 to 147.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
11.85 to 44.01
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n =175, 166) 1.1 66.3
Week 24 (n =175, 173) 1.1 60.7
Week 52 (n =169, 171) 0.6 53.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 200.8
Confidence Interval (2-Sided) 95%
47.16 to 854.60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 228.0
Confidence Interval (2-Sided) 95%
51.95 to 1000.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF­-04950615
Comments Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 259.9
Confidence Interval (2-Sided) 95%
34.87 to 1937.06
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Hide Description [Not Specified]
Time Frame Week 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.
Arm/Group Title PF­-04950615
Hide Arm/Group Description:
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter
Week 12 (n =163) 6.23  (5.657)
Week 24 (n =167) 7.00  (6.351)
Week 52 (n =171) 4.84  (5.384)
28.Secondary Outcome
Title Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Hide Description Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.
Time Frame Baseline up to the end of study (up to 58 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description:
Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Unit of Measure: participants
With Type 1 or 3 hypersensitivity reactions 0 0
With Injection site reactions 1 38
29.Secondary Outcome
Title Percentage of Participants With Positive Anti­Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Hide Description Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.
Time Frame Baseline up to the end of study (up to 58 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who received at least 1 dose of PF-04950615.
Arm/Group Title PF­-04950615
Hide Arm/Group Description:
Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed 185
Measure Type: Number
Unit of Measure: percentage of participants
With positive ADA 49.7
With positive nAb 33
Time Frame Baseline up to the end of study (up to 58 weeks)
Adverse Event Reporting Description The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
 
Arm/Group Title Placebo PF­-04950615
Hide Arm/Group Description Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
All-Cause Mortality
Placebo PF­-04950615
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo PF­-04950615
Affected / at Risk (%) Affected / at Risk (%)
Total   22/185 (11.89%)   24/185 (12.97%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/185 (0.54%)  0/185 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * 1  0/185 (0.00%)  2/185 (1.08%) 
Angina pectoris * 1  3/185 (1.62%)  1/185 (0.54%) 
Angina unstable * 1  0/185 (0.00%)  1/185 (0.54%) 
Atrial fibrillation * 1  0/185 (0.00%)  1/185 (0.54%) 
Myocardial infarction * 1  1/185 (0.54%)  1/185 (0.54%) 
Myocardial ischaemia * 1  0/185 (0.00%)  1/185 (0.54%) 
Supraventricular tachycardia * 1  1/185 (0.54%)  0/185 (0.00%) 
Eye disorders     
Retinal artery occlusion * 1  1/185 (0.54%)  0/185 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/185 (0.00%)  1/185 (0.54%) 
Gastritis erosive * 1  0/185 (0.00%)  1/185 (0.54%) 
Haematochezia * 1  1/185 (0.54%)  0/185 (0.00%) 
Pancreatitis acute * 1  1/185 (0.54%)  0/185 (0.00%) 
General disorders     
Chest discomfort * 1  0/185 (0.00%)  1/185 (0.54%) 
Sudden cardiac death * 1  0/185 (0.00%)  1/185 (0.54%) 
Vascular stent restenosis * 1  0/185 (0.00%)  1/185 (0.54%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/185 (0.00%)  1/185 (0.54%) 
Infections and infestations     
Appendicitis * 1  1/185 (0.54%)  0/185 (0.00%) 
Bronchitis * 1  0/185 (0.00%)  1/185 (0.54%) 
Diverticulitis * 1  1/185 (0.54%)  0/185 (0.00%) 
Gastroenteritis viral * 1  1/185 (0.54%)  0/185 (0.00%) 
Lower respiratory tract infection * 1  1/185 (0.54%)  0/185 (0.00%) 
Pulmonary tuberculosis * 1  0/185 (0.00%)  1/185 (0.54%) 
Pyelonephritis * 1  0/185 (0.00%)  1/185 (0.54%) 
Wound sepsis * 1  1/185 (0.54%)  0/185 (0.00%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence * 1  0/185 (0.00%)  1/185 (0.54%) 
Ankle fracture * 1  1/185 (0.54%)  0/185 (0.00%) 
Incisional hernia * 1  0/185 (0.00%)  1/185 (0.54%) 
Joint dislocation * 1  1/185 (0.54%)  0/185 (0.00%) 
Lumbar vertebral fracture * 1  0/185 (0.00%)  1/185 (0.54%) 
Postoperative ileus * 1  1/185 (0.54%)  0/185 (0.00%) 
Tendon rupture * 1  1/185 (0.54%)  0/185 (0.00%) 
Metabolism and nutrition disorders     
Obesity * 1  0/185 (0.00%)  1/185 (0.54%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis * 1  1/185 (0.54%)  0/185 (0.00%) 
Osteoarthritis * 1  1/185 (0.54%)  0/185 (0.00%) 
Rotator cuff syndrome * 1  0/185 (0.00%)  1/185 (0.54%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Appendix cancer * 1  0/185 (0.00%)  1/185 (0.54%) 
Bladder neoplasm * 1  1/185 (0.54%)  0/185 (0.00%) 
Lung neoplasm malignant * 1  0/185 (0.00%)  1/185 (0.54%) 
Ovarian neoplasm * 1  0/185 (0.00%)  1/185 (0.54%) 
Pancreatic carcinoma * 1  0/185 (0.00%)  1/185 (0.54%) 
Nervous system disorders     
Ischaemic stroke * 1  1/185 (0.54%)  0/185 (0.00%) 
Migraine * 1  1/185 (0.54%)  0/185 (0.00%) 
Syncope * 1  0/185 (0.00%)  2/185 (1.08%) 
Product Issues     
Device breakage * 1  0/185 (0.00%)  1/185 (0.54%) 
Psychiatric disorders     
Depression * 1  0/185 (0.00%)  1/185 (0.54%) 
Psychotic disorder * 1  0/185 (0.00%)  1/185 (0.54%) 
Renal and urinary disorders     
Calculus bladder * 1  1/185 (0.54%)  0/185 (0.00%) 
Nephrolithiasis * 1  1/185 (0.54%)  0/185 (0.00%) 
Renal colic * 1  1/185 (0.54%)  0/185 (0.00%) 
Urinary retention * 1  0/185 (0.00%)  1/185 (0.54%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1 [1]  0/103 (0.00%)  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/185 (0.00%)  1/185 (0.54%) 
Dyspnoea * 1  0/185 (0.00%)  1/185 (0.54%) 
Dyspnoea exertional * 1  1/185 (0.54%)  0/185 (0.00%) 
Vascular disorders     
Peripheral ischaemia * 1  0/185 (0.00%)  1/185 (0.54%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
[1]
This is gender specific event. The number of participants evaluable for this event are 103 and 112.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PF­-04950615
Affected / at Risk (%) Affected / at Risk (%)
Total   36/185 (19.46%)   70/185 (37.84%) 
General disorders     
Injection site reaction * 1  1/185 (0.54%)  38/185 (20.54%) 
Infections and infestations     
Influenza * 1  6/185 (3.24%)  10/185 (5.41%) 
Nasopharyngitis * 1  15/185 (8.11%)  15/185 (8.11%) 
Upper respiratory tract infection * 1  7/185 (3.78%)  11/185 (5.95%) 
Nervous system disorders     
Headache * 1  10/185 (5.41%)  10/185 (5.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968980     History of Changes
Other Study ID Numbers: B1481021
2013-002644-87 ( EudraCT Number )
SPIRE-HF ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2013
First Posted: October 24, 2013
Results First Submitted: April 7, 2017
Results First Posted: May 19, 2017
Last Update Posted: June 26, 2017