CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
MK-5478 +2 moredrug
Likely dose
MK-5478 38 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01025843
NCT01025843Phase 1Completed
CompareCT.gov

A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension

Merck Sharp & Dohme LLC·interventional·Posted Dec 4, 2009·Updated Sep 21, 2018

In Brief

A Phase 1 clinical trial evaluating MK-5478, Comparator: Candesartan cilexetil, and 1 other intervention for Hypertension. Completed, enrolled 20 participants.

Detailed Summary

This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.6 years ago

Interventions

MK-5478drug

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetildrug

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbodrug

Placebo