drugset / Trial / NCT01370655

A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)

NCT01370655

Phase 1 Completed 46 enrolled Merck Sharp & Dohme LLC
RandomizedCrossoverDouble-blindTreatment

Summary

This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension. The primary hypotheses for the study were as follows: 1. Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure (SBP) in male participants with mild to moderate hypertension that is superior to placebo, as measured by time weighted average change from baseline over 24 hours postdose (TWA0-24hrs) on dosing Day 28 2. Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide (HCTZ), as measured by TWA0-24hrs on dosing Day 28 3. The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood pressure (DBP), both as measured by TWA0-24hrs, will be estimated 4. Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated.

Timeline

Start
2011-06-15
Primary completion
2011-12-19
Completion
2012-01-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 25 mg
Subject MK-7145 Small molecule 3 mg Oral
Subject MK-7145 Small molecule 6 mg Oral

Indications