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Trial record 28 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)

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: NCT01431508
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : November 22, 2011
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: Losartan 50 mg / HCTZ 12.5 mg
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Losartan 50 mg / HCTZ 12.5 mg
Hide Arm/Group Description Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
Period Title: Overall Study
Started 15
Completed 13
Not Completed 2
Reason Not Completed
Lack of Efficacy             1
Unable to Follow Protocol Procedures             1
Arm/Group Title Losartan 50 mg / HCTZ 12.5 mg
Hide Arm/Group Description Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
50.5  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
1.Primary Outcome
Title Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Hide Description Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.
Time Frame At Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Losartan 50 mg / HCTZ 12.5 mg
Hide Arm/Group Description:
Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline (N = 15) 99.2  (5.5)
Change from Baseline at Week 12 (N = 13) -12.7  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan 50 mg / HCTZ 12.5 mg
Comments Comparison of Week 12 and Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan 50 mg/HCTZ 12.5 mg
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Losartan 50 mg/HCTZ 12.5 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan 50 mg/HCTZ 12.5 mg
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Losartan 50 mg/HCTZ 12.5 mg
Affected / at Risk (%) # Events
Total   8/15 (53.33%)    
Cardiac disorders   
ARRHYTHMIA  1  1/15 (6.67%)  1
PALPITATIONS  1  1/15 (6.67%)  1
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/15 (6.67%)  1
GASTRITIS  1  1/15 (6.67%)  1
Investigations   
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/15 (6.67%)  1
BLOOD CHOLESTEROL INCREASED  1  1/15 (6.67%)  1
BLOOD GLUCOSE ABNORMAL  1  2/15 (13.33%)  2
BLOOD POTASSIUM DECREASED  1  1/15 (6.67%)  1
BLOOD SODIUM INCREASED  1  1/15 (6.67%)  1
BLOOD TRIGLYCERIDES INCREASED  1  2/15 (13.33%)  2
BLOOD UREA INCREASED  1  1/15 (6.67%)  1
BLOOD URIC ACID INCREASED  1  3/15 (20.00%)  3
Musculoskeletal and connective tissue disorders   
MYALGIA  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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: NCT01431508     History of Changes
Other Study ID Numbers: 0954A-373
First Submitted: September 7, 2011
First Posted: September 9, 2011
Results First Submitted: October 13, 2011
Results First Posted: November 22, 2011
Last Update Posted: May 5, 2017