Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)

NCT01337674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-12-24

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Summary

This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of the study is that MK-4618 does not result in a clinically meaningful change in systolic blood pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.

Conditions

Interventions

DRUG

MK-4618

Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7

DRUG

Placebo for MK-4618

Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7

DRUG

Metoprolol

Previously prescribed daily dose of open-label metoprolol for the duration of the study

DRUG

Amlodipine

Previously prescribed daily dose of open-label amlodipine for the duration of the study

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-01
Primary Completion
2011-11-01
Completion
2011-11-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337674 on ClinicalTrials.gov