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 23, 2014
Last verified: June 2014
  Purpose

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Condition Intervention Phase
Hypertension
Drug: MK0736
Drug: MK0916
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.

  • Number of Participants Who Reported a Clinical Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  • Number of Participants Who Reported a Laboratory Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

  • Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.

  • Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.

  • 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) ] [ Designated as safety issue: No ]
    Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.

  • Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI [ Time Frame: Baseline and Week 12 (end of Phase A) ] [ Designated as safety issue: No ]
    Waist circumference measured in cm at baseline and after 12 weeks of study drug administration

  • 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) ] [ Designated as safety issue: No ]
    LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.

  • 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) ] [ Designated as safety issue: No ]
    HDL-C measured at baseline and after 12 weeks of study drug administration.

  • 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) ] [ Designated as safety issue: No ]
    TG measured at baseline and after 12 weeks of study drug administration


Enrollment: 249
Study Start Date: November 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: MK0736 Drug: Placebo
Experimental: 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)
Drug: MK0736 Drug: Placebo
Experimental: 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)
Drug: MK0916
Placebo Comparator: High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Drug: Placebo
Experimental: 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)
Drug: MK0916
Placebo Comparator: Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Drug: Placebo

Detailed Description:

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Exclusion Criteria:

  • Pre-menopausal women
  • patients currently taking more than two (2) blood pressure lowering medications
  • Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
  • History of Alcohol abuse (<3 Years)
  • History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274716

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional 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 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014