A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00546052
First received: October 17, 2007
Last updated: November 22, 2013
Last verified: November 2013
Results First Received: January 8, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Metabolic Disorder
Intervention: Drug: losartan potassium (+) hydrochlorothiazide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.

Reporting Groups
  Description
Losartan +/- Hydrochlorothiazide Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Participant Flow:   Overall Study
    Losartan +/- Hydrochlorothiazide  
STARTED     1738  
Week 4     1714  
Week 8     1680  
Week 12     1650  
Week 32     1583  
Week 52     1511  
COMPLETED     1511  
NOT COMPLETED     227  
Adverse Event                 47  
Lost to Follow-up                 144  
Protocol Violation                 9  
Withdrawal by Subject                 20  
Non Compliance                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Losartan +/- Hydrochlorothiazide Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Baseline Measures
    Losartan +/- Hydrochlorothiazide  
Number of Participants  
[units: participants]
  1714  
Age  
[units: Years]
Mean ± Standard Deviation
  54.93  ± 11.29  
Age, Customized  
[units: participants]
 
<=45.00     326  
45.01 - 52.00     359  
52.01 - 58.00     356  
58.01 - 65.00     346  
>=65.00     326  
Missing     1  
Gender  
[units: participants]
 
Female     734  
Male     980  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     1451  
Black     32  
Asian     200  
Native American     11  
Other     19  
Missing     1  
Body Mass Index  
[units: Kg/m2]
Mean ± Standard Deviation
  33.23  ± 5.59  
C-Reactive Protein  
[units: mg/L]
Mean ± Standard Deviation
  5.4  ± 8.8  
Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  90.54  ± 8.16  
Fasting Blood Glucose  
[units: mmol/L]
Mean ± Standard Deviation
  5.7  ± 0.7  
Heart Rate  
[units: Beats per Minute (BPM)]
Mean ± Standard Deviation
  75  ± 8.0  
Hemoglobin A1c  
[units: Percent]
Mean ± Standard Deviation
  5.71  ± 0.59  
High Density Lipoprotein-C  
[units: mol/L]
Mean ± Standard Deviation
  1.23  ± 0.33  
Low Density Lipoprotein-C  
[units: mmol/L]
Mean ± Standard Deviation
  3.17  ± 0.93  
Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  148.22  ± 10.72  
Total Cholesterol  
[units: mmol/L]
Mean ± Standard Deviation
  5.36  ± 1.05  
Triglycerides  
[units: mmol/L]
Mean ± Standard Deviation
  2.16  ± 1.16  
Uric Acid  
[units: mmol/L]
Mean ± Standard Deviation
  365.8  ± 85.4  
Weight  
[units: Kilograms (Kg)]
Mean ± Standard Deviation
  92.5  ± 18.1  



  Outcome Measures
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1.  Primary:   Change in Hemoglobin A1c Between 52 Weeks and Baseline   [ Time Frame: 52 Weeks - Baseline ]

2.  Primary:   Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments   [ Time Frame: 52 Weeks - Baseline ]

3.  Secondary:   Target Blood Pressure   [ Time Frame: 52 Weeks ]

4.  Secondary:   Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

5.  Secondary:   Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

6.  Other Pre-specified:   Change in Waist Circumference Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

7.  Other Pre-specified:   Change in Body Mass Index Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

8.  Other Pre-specified:   Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

9.  Other Pre-specified:   Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

10.  Other Pre-specified:   Percent Change in Triglycerides Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

11.  Other Pre-specified:   Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

12.  Other Pre-specified:   Absolute Change in Uric Acid Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]

13.  Other Pre-specified:   Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments   [ Time Frame: 52 Weeks - Baseline ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00546052     History of Changes
Other Study ID Numbers: 0954-331, MK0954A-331, 2007_030
Study First Received: October 17, 2007
Results First Received: January 8, 2009
Last Updated: November 22, 2013
Health Authority: Canada: Health Canada