Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)

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: NCT01368185
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : September 1, 2011
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Hypertension
Enrollment 1705
Recruitment Details All the medical charts of the eligible study patients were reviewed. The study index period (when patients had to have received treatment for 3 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively between November 2008 and August 2010.
Pre-assignment Details 1735 patients were enrolled into this study. Among them, 1705 patients were eligible after excluding 30 patients.
Arm/Group Title All Participants
Hide Arm/Group Description Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Period Title: Overall Study
Started 1705
Completed 1705
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Overall Number of Baseline Participants 1705
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1705 participants
57.9  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1705 participants
Female
795
  46.6%
Male
910
  53.4%
1.Primary Outcome
Title Serum Uric Acid (SUA) Level
Hide Description SUA at baseline and Month 3.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Overall Number of Participants Analyzed 1705
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 6.4  (1.6)
Month 3 6.6  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Comparison between Month 3 and Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter % change SUA from baseline
Estimated Value 4.6
Parameter Dispersion
Type: Standard Deviation
Value: 0.9
Estimation Comments Percent change of month 3 SUA minus baseline SUA.
2.Secondary Outcome
Title The Percentage of Patients With Hyperuricemia
Hide Description Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Overall Number of Participants Analyzed 1705
Measure Type: Number
Unit of Measure: percent of participants
Baseline 27.0
Month 3 14.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
3.Secondary Outcome
Title Diastolic Blood Pressure (DBP)
Hide Description DBP at baseline and month 3.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Overall Number of Participants Analyzed 1705
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 89  (13)
Month 3 81  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Comparison between Month 3 and Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter % change DBP from Baseline
Estimated Value -7.1
Parameter Dispersion
Type: Standard Deviation
Value: 0.4
Estimation Comments Percent change of month 3 DBP minus baseline DBP (n=1239).
4.Secondary Outcome
Title Systolic Blood Pressure (SBP)
Hide Description SBP at baseline and month 3.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
Overall Number of Participants Analyzed 1705
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 150  (19)
Month 3 135  (15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Comparison between Month 3 and Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter % change SBP from Baseline
Estimated Value -9.1
Parameter Dispersion
Type: Standard Deviation
Value: 0.3
Estimation Comments Percent change of month 3 SBP minus baseline SBP (n=1245).
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/1705 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   7/1705 (0.41%)    
Cardiac disorders   
Tachycardia/Palpitation  2/1705 (0.12%)  2
Nervous system disorders   
Dizziness  3/1705 (0.18%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea with wheezing  1/1705 (0.06%)  1
Mild cough  1/1705 (0.06%)  1
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: NCT01368185     History of Changes
Other Study ID Numbers: 0954A-366
MK-0954A-366
First Submitted: June 6, 2011
First Posted: June 7, 2011
Results First Submitted: August 2, 2011
Results First Posted: September 1, 2011
Last Update Posted: October 12, 2015