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

NCT ID: NCT00543413

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arm 1: Drug 250 mg

Group Type EXPERIMENTAL

MK8141

Intervention Type DRUG

MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period

2

Arm 2: Drug 500 mg

Group Type EXPERIMENTAL

MK8141

Intervention Type DRUG

MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period

3

Arm 3: Active Comparator

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

Enalapril 20 mg tablet once daily. 4 week treatment period.

4

Arm 4: Pbo Comparator

Group Type PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type DRUG

MK8141 Pbo tablet once daily. 4 week treatment period.

Interventions

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MK8141

MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period

Intervention Type DRUG

Comparator: placebo (unspecified)

MK8141 Pbo tablet once daily. 4 week treatment period.

Intervention Type DRUG

Enalapril

Enalapril 20 mg tablet once daily. 4 week treatment period.

Intervention Type DRUG

Other Intervention Names

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Vasotec®

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P. Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension. J Am Soc Hypertens. 2010 Sep-Oct;4(5):219-26. doi: 10.1016/j.jash.2010.06.006. Epub 2010 Aug 12.

Reference Type RESULT
PMID: 20705534 (View on PubMed)

Other Identifiers

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MK8141-006

Identifier Type: -

Identifier Source: secondary_id

2007_587

Identifier Type: -

Identifier Source: secondary_id

8141-006

Identifier Type: -

Identifier Source: org_study_id

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