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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 23, 2014
Last verified: June 2014

January 10, 2006
June 23, 2014
November 2005
January 2007   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00274716 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK0736
  • Drug: MK0916
  • Drug: Placebo
  • 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)
    Interventions:
    • 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)
    Interventions:
    • 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Drug: Placebo
Shah S, Hermanowski-Vosatka A, Gibson K, Ruck RA, Jia G, Zhang J, Hwang PM, Ryan NW, Langdon RB, Feig PU. Efficacy and safety of the selective 11β-HSD-1 inhibitors MK-0736 and MK-0916 in overweight and obese patients with hypertension. J Am Soc Hypertens. 2011 May-Jun;5(3):166-76. doi: 10.1016/j.jash.2011.01.009. Epub 2011 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00274716
0736-003, 2006_004
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP