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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: MK0916; Drug: MK0736

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.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Drug: MK0736
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: Placebo; Drug: MK0736
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)	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.	Baseline and Week 12 (end of Phase A)
Number of Participants Who Reported a Clinical Adverse Event	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.	24 weeks
Number of Participants Who Reported a Laboratory Adverse Event	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.	24 weeks
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event	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.	24 weeks
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)	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.	Baseline and Week 12 (end of Phase A)
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI	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.	Baseline and Week 12 (end of Phase A)
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI	Waist circumference measured in cm at baseline and after 12 weeks of study drug administration	Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)	LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.	Baseline and Week 12 (end of Phase A)
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI	HDL-C measured at baseline and after 12 weeks of study drug administration.	Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)	TG measured at baseline and after 12 weeks of study drug administration	Baseline and Week 12 (end of Phase A)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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 11beta-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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: January 10, 2006
• First Submitted That Met QC Criteria: January 10, 2006
• First Posted (Estimate): January 11, 2006

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 0736-003; 2006_004