Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)

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: NCT01299376
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : January 26, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: L50/H12.5/A5
Drug: L50/H12.5
Drug: Placebo to L50/H12.5/A5
Drug: Placebo to L50/H12.5
Enrollment 286
Recruitment Details  
Pre-assignment Details All participants received single–blind losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5) and placebo for L50/H12.5/amlodipine 5 mg (A5) during 8-week Filter Period. A total of 510 entered the Filter Period and 286 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension. One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Period Title: Double-blind Treatment (Weeks 1 to 8)
Started 141 145
Completed 134 133
Not Completed 7 12
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             0             1
Lost to Follow-up             0             1
Blood Pressure/Potassium Criteria Met             4             7
Protocol Violation             1             0
Withdrawal by Subject             1             1
Period Title: Extension (Weeks 9 to 52)
Started 134 133
Completed 124 118
Not Completed 10 15
Reason Not Completed
Withdrawal by Subject             2             1
Adverse Event             2             3
Lost to Follow-up             1             2
Blood Pressure/Potassium Criteria Met             4             9
Physician Decision             1             0
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5 Total
Hide Arm/Group Description One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension. One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension. Total of all reporting groups
Overall Number of Baseline Participants 141 145 286
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 145 participants 286 participants
53.9  (9.1) 56.3  (9.7) 55.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 145 participants 286 participants
Female
33
  23.4%
34
  23.4%
67
  23.4%
Male
108
  76.6%
111
  76.6%
219
  76.6%
1.Primary Outcome
Title Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period
Hide Description Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-12.1
(-13.3 to -10.9)
-6.2
(-7.4 to -5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection L50/H12.5/A5, L50/H12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Contrained Longitudinal Data Analysis
Comments Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.
Method of Estimation Estimation Parameter Difference in Least-squares Means
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-7.5 to -4.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.
Time Frame up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 145
Measure Type: Number
Unit of Measure: Percentage of Participants
27.0 29.7
3.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.
Time Frame up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 145
Measure Type: Number
Unit of Measure: Percentage of Participants
12.1 14.5
4.Primary Outcome
Title Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period
Hide Description An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.
Time Frame up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 145
Measure Type: Number
Unit of Measure: Percentage of Participants
0.7 1.4
5.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period
Hide Description An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.
Time Frame up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 145
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0
6.Primary Outcome
Title Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.
Time Frame up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 145
Measure Type: Number
Unit of Measure: Percentage of Participants
0.7 1.4
7.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.
Time Frame Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during long-term reporting period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description:
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Overall Number of Participants Analyzed 141 133
Measure Type: Number
Unit of Measure: Percentage of Participants
70.9 66.2
8.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.
Time Frame Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during long-term reporting period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description:
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Overall Number of Participants Analyzed 141 133
Measure Type: Number
Unit of Measure: Percentage of Participants
27.7 14.3
9.Primary Outcome
Title Percentage of Participants Who Experience 1 or More SAEs- Long Term
Hide Description An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.
Time Frame Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during long-term reporting period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description:
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Overall Number of Participants Analyzed 141 133
Measure Type: Number
Unit of Measure: Percentage of Participants
2.1 3.0
10.Primary Outcome
Title Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term
Hide Description An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.
Time Frame Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during long-term reporting period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description:
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Overall Number of Participants Analyzed 141 133
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.8
11.Primary Outcome
Title Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.
Time Frame Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug during extension period.
Arm/Group Title L50/H12.5/A5→L50/H12.5/A5 L50/H12.5→L50/H12.5/A5
Hide Arm/Group Description:
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Overall Number of Participants Analyzed 141 133
Measure Type: Number
Unit of Measure: Percentage of Participants
2.1 2.3
12.Secondary Outcome
Title Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period
Hide Description Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data
Arm/Group Title L50/H12.5/A5 L50/H12.5
Hide Arm/Group Description:
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
Overall Number of Participants Analyzed 141 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-17.7
(-19.6 to -15.9)
-7.5
(-9.3 to -5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection L50/H12.5/A5, L50/H12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.
Method Constrained Longitudinal Data Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-12.8 to -7.7
Estimation Comments [Not Specified]
Time Frame Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug during the reporting period.
 
Arm/Group Title L50/H12.5- Double Blind Treatment Period L50/H12.5/A5 - Double Blind Treatment Period L50/H12.5/A5→L50/H12.5/A5 - Extension L50/H12.5→L50/H12.5/A5 - Extension
Hide Arm/Group Description Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period. Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
All-Cause Mortality
L50/H12.5- Double Blind Treatment Period L50/H12.5/A5 - Double Blind Treatment Period L50/H12.5/A5→L50/H12.5/A5 - Extension L50/H12.5→L50/H12.5/A5 - Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
L50/H12.5- Double Blind Treatment Period L50/H12.5/A5 - Double Blind Treatment Period L50/H12.5/A5→L50/H12.5/A5 - Extension L50/H12.5→L50/H12.5/A5 - Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/145 (1.38%)      1/141 (0.71%)      2/134 (1.49%)      4/133 (3.01%)    
Eye disorders         
Cataract  1  0/145 (0.00%)  0 1/141 (0.71%)  1 0/134 (0.00%)  0 0/133 (0.00%)  0
Gastrointestinal disorders         
Colonic polyp  1  1/145 (0.69%)  1 0/141 (0.00%)  0 1/134 (0.75%)  1 0/133 (0.00%)  0
Haemorrhoids  1  1/145 (0.69%)  1 0/141 (0.00%)  0 0/134 (0.00%)  0 0/133 (0.00%)  0
Enterocele  1  0/145 (0.00%)  0 0/141 (0.00%)  0 0/134 (0.00%)  0 1/133 (0.75%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Carcinoid tumour of the duodenum  1  0/145 (0.00%)  0 0/141 (0.00%)  0 1/134 (0.75%)  1 0/133 (0.00%)  0
Liposarcoma  1  0/145 (0.00%)  0 0/141 (0.00%)  0 0/134 (0.00%)  0 1/133 (0.75%)  1
Malignant neoplasm of renal pelvis  1  0/145 (0.00%)  0 0/141 (0.00%)  0 0/134 (0.00%)  0 1/133 (0.75%)  1
Nervous system disorders         
Altered state of consciousness  1  0/145 (0.00%)  0 0/141 (0.00%)  0 0/134 (0.00%)  0 1/133 (0.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
L50/H12.5- Double Blind Treatment Period L50/H12.5/A5 - Double Blind Treatment Period L50/H12.5/A5→L50/H12.5/A5 - Extension L50/H12.5→L50/H12.5/A5 - Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/145 (12.41%)      10/141 (7.09%)      39/134 (29.10%)      42/133 (31.58%)    
Infections and infestations         
Nasopharyngitis  1  9/145 (6.21%)  9 3/141 (2.13%)  3 30/134 (22.39%)  35 30/133 (22.56%)  44
Investigations         
Blood uric acid increased  1  10/145 (6.90%)  10 7/141 (4.96%)  7 4/134 (2.99%)  5 7/133 (5.26%)  7
Alanine aminotransferase increased  1  0/145 (0.00%)  0 3/141 (2.13%)  3 7/134 (5.22%)  7 7/133 (5.26%)  7
Musculoskeletal and connective tissue disorders         
Back pain  1  1/145 (0.69%)  1 1/141 (0.71%)  1 4/134 (2.99%)  4 7/133 (5.26%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.0
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01299376     History of Changes
Other Study ID Numbers: 0954E-356
First Submitted: February 16, 2011
First Posted: February 18, 2011
Results First Submitted: December 1, 2016
Results First Posted: January 26, 2017
Last Update Posted: August 22, 2018