DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010 AM1)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: MK-4618 (Drug); Placebo for MK-4618 (Drug); metoprolol (Drug); amlodipine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of participants who experience clinical or laboratory adverse events

Change from baseline in systolic blood pressure

Change from baseline in systolic blood pressure

Secondary outcome: Steady-state area under the concentration versus time curve [AUC(0-24hr)] for MK-4618

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female not of childbearing potential

- Not a nursing mother

- Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only)

for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take the designated daily dose of metoprolol or amlodipine for the duration of the study

- In good health other than hypertension

- Nonsmoker

- Participant has a resting systolic blood pressure of <160 mmHg and a diastolic blood

pressure <100 mmHg prior to randomization Exclusion Criteria:

- Any illness that might confound the results of the study or pose a risk by

participation

- History of orthostatic hypotension (decrease in blood pressure upon standing

accompanied by symptoms of lightheadedness or dizziness)

- History of cancer, excepting certain skin or cervical cancers or cancers that were

treated successfully 10 or more years prior to screening

- Condition for which there is a warning, contraindication, or precaution against the

use of extended release metoprolol (Panel A) or amlodipine (Panel B)

- Consumes excessive amounts of alcohol or caffeine daily

- Has multiple and/or severe allergies (including latex allergy) or has had an

anaphylactic reaction or significant intolerance to drugs or food

- Uses illicit drugs or has a history of drug abuse

Locations and Contacts

Additional Information

Starting date: April 2011
Last updated: December 17, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017