Clinical trial NCT00274716: Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Number of Participants Who Reported a Clinical Adverse Event
timeFrame: 24 weeks
measure: Number of Participants Who Reported a Laboratory Adverse Event
timeFrame: 24 weeks
measure: Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
timeFrame: 24 weeks
measure: Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
timeFrame: Baseline and Week 12 (end of Phase A)
measure: Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
timeFrame: Baseline and Week 12 (end of Phase A)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.