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Trial record 70 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

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ClinicalTrials.gov Identifier: NCT01307046
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : March 22, 2013
Last Update Posted : May 5, 2017
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: MK-0954A
Drug: Losartan
Drug: Placebo to MK-0954A
Drug: Placebo to losartan 100 mg
Drug: Placebo to losartan 50 mg
Enrollment 336
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-0954A Losartan
Hide Arm/Group Description Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Period Title: Overall Study
Started 166 170
Completed 154 159
Not Completed 12 11
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             0             2
Physician Decision             2             0
Withdrawal by Subject             1             1
Serum Potassium Withdrawal Criteria Met             4             2
Blood Pressure Withdrawal Criteria Met             2             3
Arm/Group Title MK-0954A Losartan Total
Hide Arm/Group Description Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 166 170 336
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 170 participants 336 participants
55.7  (9.2) 54.9  (9.5) 55.3  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 170 participants 336 participants
Female
37
  22.3%
60
  35.3%
97
  28.9%
Male
129
  77.7%
110
  64.7%
239
  71.1%
1.Primary Outcome
Title Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
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 (Day 56 ± 7 days).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent

to at least one dose of study treatment, and had baseline data for those analyses that required baseline data

Arm/Group Title MK-0954A Losartan
Hide Arm/Group Description:
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Overall Number of Participants Analyzed 166 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-8.7
(-9.9 to -7.6)
-3.6
(-4.8 to -2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0954A, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method constrained longitudinal data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-6.8 to -3.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.
Arm/Group Title MK-0954A Losartan
Hide Arm/Group Description:
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Overall Number of Participants Analyzed 166 170
Measure Type: Number
Unit of Measure: percentage of participants
31.3 26.5
3.Secondary Outcome
Title Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
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 (Day 56 ± 7 days).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent

to at least one dose of study treatment, and had baseline data for those analyses that required baseline data

Arm/Group Title MK-0954A Losartan
Hide Arm/Group Description:
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Overall Number of Participants Analyzed 166 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-14.5
(-16.5 to -12.6)
-5.4
(-7.3 to -3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0954A, Losartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method constrained longitudinal data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-11.9 to -6.5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-0954A Losartan
Hide Arm/Group Description Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
All-Cause Mortality
MK-0954A Losartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-0954A Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/166 (0.00%)      0/170 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0954A Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/166 (5.42%)      9/170 (5.29%)    
Infections and infestations     
Nasopharyngitis   9/166 (5.42%)  11 9/170 (5.29%)  10
Indicates events were collected by systematic assessment
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. The 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: Merch 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: NCT01307046     History of Changes
Other Study ID Numbers: 0954A-352
First Submitted: March 1, 2011
First Posted: March 2, 2011
Results First Submitted: January 2, 2013
Results First Posted: March 22, 2013
Last Update Posted: May 5, 2017