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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: June 8, 2015
Last verified: June 2015
Results First Received: December 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: MK0736
Drug: MK0916
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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.


  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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: June 8, 2015