CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
MK-3614 +1 moredrug
Likely dose
MK-3614 0.25 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/NCT01033643
NCT01033643Phase 1Completed

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-3614

Merck Sharp & Dohme LLC·interventional·Posted Dec 16, 2009·Updated May 3, 2021

In Brief

A Phase 1 clinical trial evaluating MK-3614 and Placebo for MK-3614 for Hypertension. Completed, enrolled 30 participants.

Detailed Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MK-3614 in male participants with mild to moderate hypertension. The primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3) Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15 beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10 bpm of baseline on last day of multiple dosing of MK-3614.

Study Details

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

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2009
Enrollment StartMay 27, 2009
Primary CompletionDec 9, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.5 years ago

Interventions

MK-3614drug

Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization.

Placebo for MK-3614drug

Participants were administered dose matched placebo tablets according to randomization.