Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: MK0736; Drug: Placebo; Drug: MK0916

Study type: Interventional

Funder types: Industry

Identifiers

NCT00274716

2006_004

0736-003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 6 patient groups, including a placebo group

High BMI:MK-0736 2mg→Placebo

Experimental group

Description:

Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)

Treatment:

Drug: Placebo

Drug: MK0736

High BMI:MK-0736 7mg→Placebo

Experimental group

Description:

Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)

Treatment:

Drug: Placebo

Drug: MK0736

High BMI:MK-0916 6mg→MK-0916 6mg

Experimental group

Description:

Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Treatment:

Drug: MK0916

High BMI:Placebo→Placebo

Placebo Comparator group

Description:

Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Treatment:

Drug: Placebo

Low BMI:MK-0916 6mg→MK-0916 6mg

Experimental group

Description:

Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Treatment:

Drug: MK0916

Low BMI:Placebo→Placebo

Placebo Comparator group

Description:

Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Treatment:

Drug: Placebo