A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)

October 15, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients

This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • You are 35 to 65 years of age
  • In the past 14 days you have not been treated for hypertension
  • In the past 14 days you have not taken more than 2 medications to treat high blood pressure
  • You are a woman who is not able to have children or do not use birth control

Exclusion Criteria:

  • You are taking more than 2 medications to treat high blood pressure
  • You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
  • You have Type 1 or 2 diabetes mellitus
  • You have an active liver disease, gallbladder disease, or bowel disease
  • You are HIV positive
  • You have certain types of cancer
  • You abuse drug or alcohol
  • You have participated in another clinical study in last 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Arm 1: Drug 250 mg
Drug: MK8141
MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Experimental: 2
Arm 2: Drug 500 mg
Drug: MK8141
MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Active Comparator: 3
Arm 3: Active Comparator
Drug: Enalapril
Enalapril 20 mg tablet once daily. 4 week treatment period.
Other Names:
  • Vasotec®
Placebo Comparator: 4
Arm 4: Pbo Comparator
Drug: Comparator: placebo (unspecified)
MK8141 Pbo tablet once daily. 4 week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
Time Frame: after 4 weeks of treatment
after 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment.
Time Frame: after 4 weeks of treatment
after 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8141-006
  • MK8141-006
  • 2007_587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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