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A Study of CK-1827452 Infusion in Stable Heart Failure

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: NCT00624442
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : August 16, 2010
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: CK-1827452
Drug: Placebo
Enrollment 45
Recruitment Details The recruitment period was from April 2007 to January 2009.
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description 4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart. 2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
Period Title: Overall Study
Started 8 9 10 8 10
Completed 8 8 [1] 8 [2] 8 8 [2]
Not Completed 0 1 2 0 2
[1]
One patient was discontinued after inadvertant overdose.
[2]
Two patients discontinued after meeting termination criteria during dosing.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Total
Hide Arm/Group Description 4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. 4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart. 2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1. Total of all reporting groups
Overall Number of Baseline Participants 8 9 10 8 10 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 10 participants 8 participants 10 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
7
  77.8%
6
  60.0%
5
  62.5%
7
  70.0%
30
  66.7%
>=65 years
3
  37.5%
2
  22.2%
4
  40.0%
3
  37.5%
3
  30.0%
15
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 10 participants 8 participants 10 participants 45 participants
59.0  (11.9) 56.0  (14.3) 62.0  (8.2) 52.6  (18.0) 57.0  (14.0) 57.5  (13.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 10 participants 8 participants 10 participants 45 participants
Female
0
   0.0%
1
  11.1%
0
   0.0%
3
  37.5%
2
  20.0%
6
  13.3%
Male
8
 100.0%
8
  88.9%
10
 100.0%
5
  62.5%
8
  80.0%
39
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 10 participants 8 participants 10 participants 45 participants
United States 0 0 0 1 2 3
Georgia 0 0 0 0 2 2
Russian Federation 0 4 4 2 1 11
United Kingdom 8 5 6 5 5 29
1.Primary Outcome
Title Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations
Hide Description Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.
Arm/Group Title >0-100 ng/mL >100-200 ng/mL >200-300 ng/mL >300-400 ng/mL >400-500 ng/mL >500 ng/mL
Hide Arm/Group Description:
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Overall Number of Participants Analyzed 32 30 27 22 17 25
Least Squares Mean (Standard Error)
Unit of Measure: msec
# of Echocardiographic Observations (no units) 84  (0) 62  (0) 42  (0) 24  (0) 20  (0) 46  (0)
Ejection Fraction msec Change from Baseline 1  (4) 18  (4) 47  (5) 58  (6) 59  (6) 80  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection >0-100 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8842
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 1
Confidence Interval (2-Sided) 95%
-7 to 8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection >100-200 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 18
Confidence Interval (2-Sided) 95%
10 to 27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection >200-300 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 47
Confidence Interval 95%
38 to 56
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection >300-400 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 58
Confidence Interval (2-Sided) 95%
46 to 70
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection >400-500 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 59
Confidence Interval (2-Sided) 95%
47 to 72
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection >500 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 80
Confidence Interval (2-Sided) 95%
71 to 89
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection >0-100 ng/mL, >100-200 ng/mL, >200-300 ng/mL, >300-400 ng/mL, >400-500 ng/mL, >500 ng/mL
Comments

All available concentration data are used in the model as a continuous variable.

p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect
2.Primary Outcome
Title Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations
Hide Description Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.
Arm/Group Title >0-100 ng/mL >100-200 ng/mL >200-300 ng/mL >300-400 ng/mL >400-500 ng/mL >500 ng/mL
Hide Arm/Group Description:
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
Overall Number of Participants Analyzed 31 28 25 21 14 23
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of change
# of Echocardiographic Observations (no units) 81  (0) 56  (0) 37  (0) 23  (0) 17  (0) 44  (0)
Fractional Shortening Percent Change from Baseline 1  (1) 1  (1) 3  (1) 3  (1) 2  (1) 5  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection >0-100 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3665
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 1
Confidence Interval (2-Sided) 95%
-1 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection >100-200 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0357
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 1
Confidence Interval (2-Sided) 95%
0 to 3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection >200-300 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 3
Confidence Interval (2-Sided) 95%
1 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection >300-400 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 3
Confidence Interval (2-Sided) 95%
1 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection >400-500 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 2
Confidence Interval (2-Sided) 95%
0 to 5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection >500 ng/mL
Comments Placebo corrected change from baseline least squares mean +/- the standard error of the mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.
Method of Estimation Estimation Parameter LSM placebo corrected diff from baseline
Estimated Value 5
Confidence Interval (2-Sided) 95%
3 to 6
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection >0-100 ng/mL, >100-200 ng/mL, >200-300 ng/mL, >300-400 ng/mL, >400-500 ng/mL, >500 ng/mL
Comments

All available concentration data are used in the model as a continuous variable.

p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance: p<0.05
Method ANCOVA
Comments ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect
3.Secondary Outcome
Title Pharmacokinetics of CK-1827452 Injection in Stable Heart Failure Patients
Hide Description [Not Specified]
Time Frame 2 days
Outcome Measure Data Not Reported
Time Frame 5 weeks
Adverse Event Reporting Description Participants were placed in bins based on their first hour loading dose or placebo. Because multiple dosing events occurred in all cohorts and some loading dose overlap occurs between Cohort 1 and 2 as well as between Cohort 3 and 4, participant numbers in this section do not match the numbers in the participant flow section.
 
Arm/Group Title Placebo Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr Cohort 2, Loading Dose of 2.2 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr Cohort 5, Loading Dose of 0.75 mg/kg/hr Cohort 5, Loading Dose of 1.0 mg/kg/hr
Hide Arm/Group Description [Not Specified] Loading dose is the first hour of IV infusion. Loading dose is the first hour of IV infusion. Loading dose is the first hour of IV infusion. Loading dose is the first hour of IV infusion. Loading dose is first hour of IV infusion. Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose. Loading dose is first hour of IV infusion. Loading dose is first hour of IV infusion. Loading dose is first hour of IV infusion. Loading dose is first hour of IV infusion. Loading dose is first hour of IV infusion.
All-Cause Mortality
Placebo Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr Cohort 2, Loading Dose of 2.2 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr Cohort 5, Loading Dose of 0.75 mg/kg/hr Cohort 5, Loading Dose of 1.0 mg/kg/hr
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr Cohort 2, Loading Dose of 2.2 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr Cohort 5, Loading Dose of 0.75 mg/kg/hr Cohort 5, Loading Dose of 1.0 mg/kg/hr
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/16 (0.00%)      0/8 (0.00%)      0/6 (0.00%)      1/1 (100.00%)      1/18 (5.56%)      1/18 (5.56%)      0/16 (0.00%)      0/2 (0.00%)      0/8 (0.00%)    
Cardiac disorders                         
Non ST elevation MI in patient with drug overdose * 1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/1 (100.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations                         
Pneumonia * 1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Metabolism and nutrition disorders                         
Septicemia in setting of diabetic foot ulcer  1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr Cohort 2, Loading Dose of 2.2 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr Cohort 5, Loading Dose of 0.75 mg/kg/hr Cohort 5, Loading Dose of 1.0 mg/kg/hr
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/41 (19.51%)      1/8 (12.50%)      0/9 (0.00%)      1/16 (6.25%)      0/8 (0.00%)      4/6 (66.67%)      1/1 (100.00%)      6/18 (33.33%)      4/18 (22.22%)      1/16 (6.25%)      1/2 (50.00%)      2/8 (25.00%)    
Cardiac disorders                         
Sinus bradycardia  1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/8 (12.50%)  1
Gastrointestinal disorders                         
Constipation  1  2/41 (4.88%)  2 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
General disorders                         
Infusion site pain  1  1/41 (2.44%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations                         
Urinary tract infection  1  1/41 (2.44%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 1/16 (6.25%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Investigations                         
Troponin increased  1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/1 (100.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 2/8 (25.00%)  2
Musculoskeletal and connective tissue disorders                         
Musculoskeletal pain  1  1/41 (2.44%)  1 1/8 (12.50%)  1 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders                         
Somnolence  1  1/41 (2.44%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/16 (6.25%)  1 0/2 (0.00%)  0 0/8 (0.00%)  0
Dizziness postural  1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Headache  1  1/41 (2.44%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Dyspnea  1  1/41 (2.44%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders                         
Orthostatic hypotension  1  2/41 (4.88%)  2 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 0/16 (0.00%)  0 1/2 (50.00%)  1 0/8 (0.00%)  0
Hypotension  1  0/41 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Other Adverse Event table shows treatment emergent adverse events that occurred in two or more patients. Total for Other Adverse Events is the number of patients affected by an adverse event where an adverse event occurred in two or more patients.
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.
Sponsor intends to publish the results of the trial in collaboration with the Investigators.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Cytokinetics, Inc.
Phone: (650) 624-3011
Layout table for additonal information
Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT00624442     History of Changes
Other Study ID Numbers: CY 1121
First Submitted: December 21, 2007
First Posted: February 27, 2008
Results First Submitted: February 28, 2010
Results First Posted: August 16, 2010
Last Update Posted: February 23, 2017