Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00274716
First received: January 10, 2006
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: December 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: MK0736
Drug: MK0916
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants were divided into 2 strata: higher body mass index (BMI) (27 kg/m^2≤BMI<41 kg/m^2) and lower BMI (20 kg/m^2≤BMI<27 kg/m^2) prior to being randomly assigned study treatment. Data from High BMI groups were to be utilized in the primary and secondary analyses; data from low BMI groups were to be utilized in exploratory analyses.

Reporting Groups
  Description
High BMI:MK-0736 2mg→Placebo Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0736 7mg→Placebo Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0916 6mg→MK-0916 6mg Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
High BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:MK-0916 6mg→MK-0916 6mg Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Participant Flow for 2 periods

Period 1:   Phase A
    High BMI:MK-0736 2mg→Placebo     High BMI:MK-0736 7mg→Placebo     High BMI:MK-0916 6mg→MK-0916 6mg     High BMI:Placebo→Placebo     Low BMI:MK-0916 6mg→MK-0916 6mg     Low BMI:Placebo→Placebo  
STARTED     54     54     52     51     19     19  
COMPLETED     43     44     44     42     16     15  
NOT COMPLETED     11     10     8     9     3     4  
Other non-reported reason                 4                 2                 1                 2                 0                 1  
Participant moved                 0                 0                 1                 0                 0                 1  
Site Terminated                 0                 0                 0                 1                 0                 0  
Protocol Violation                 1                 0                 0                 1                 0                 0  
Met criteria for discontinuation                 1                 1                 0                 0                 0                 0  
Withdrawal by Subject                 2                 2                 1                 3                 0                 1  
Adverse Event                 2                 3                 3                 0                 2                 0  
Completed but did not enter Phase B                 1                 2                 2                 2                 1                 1  

Period 2:   Phase B
    High BMI:MK-0736 2mg→Placebo     High BMI:MK-0736 7mg→Placebo     High BMI:MK-0916 6mg→MK-0916 6mg     High BMI:Placebo→Placebo     Low BMI:MK-0916 6mg→MK-0916 6mg     Low BMI:Placebo→Placebo  
STARTED     43     44     44     42     16     15  
COMPLETED     42     40     41     41     16     14  
NOT COMPLETED     1     4     3     1     0     1  
Adverse Event                 0                 0                 2                 0                 0                 1  
Protocol Violation                 0                 2                 0                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0                 0                 0  
Participant moved                 1                 0                 0                 0                 0                 0  
Other non-reported reason                 0                 0                 1                 1                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 0                 0  



  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
High BMI:MK-0736 2mg→Placebo Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0736 7mg→Placebo Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0916 6mg→MK-0916 6mg Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
High BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:MK-0916 6mg→MK-0916 6mg Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Total Total of all reporting groups

Baseline Measures
    High BMI:MK-0736 2mg→Placebo     High BMI:MK-0736 7mg→Placebo     High BMI:MK-0916 6mg→MK-0916 6mg     High BMI:Placebo→Placebo     Low BMI:MK-0916 6mg→MK-0916 6mg     Low BMI:Placebo→Placebo     Total  
Number of Participants  
[units: participants]
  54     54     52     51     19     19     249  
Age, Customized  
[units: Participants]
             
21 to 30 years     0     1     0     1     0     0     2  
31 to 40 years     3     3     0     6     0     0     12  
41 to 50 years     10     17     20     14     6     4     71  
51 to 60 years     26     20     20     17     9     9     101  
61 to 70 years     14     12     12     13     4     6     61  
>70 years     1     1     0     0     0     0     2  
Gender  
[units: Participants]
             
Female     30     17     20     13     6     10     96  
Male     24     37     32     38     13     9     153  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

2.  Primary:   Number of Participants Who Reported a Clinical Adverse Event   [ Time Frame: 24 weeks ]

3.  Primary:   Number of Participants Who Reported a Laboratory Adverse Event   [ Time Frame: 24 weeks ]

4.  Primary:   Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event   [ Time Frame: 24 weeks ]

5.  Primary:   Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event   [ Time Frame: 24 weeks ]

6.  Secondary:   Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

7.  Secondary:   Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

8.  Secondary:   Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

9.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

10.  Secondary:   Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI   [ Time Frame: Baseline and Week 12 (end of Phase A) ]

11.  Secondary:   Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)   [ Time Frame: Baseline and Week 12 (end of Phase A) ]


  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, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00274716     History of Changes
Other Study ID Numbers: 0736-003, 2006_004
Study First Received: January 10, 2006
Results First Received: December 23, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration