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

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: MK8141 (Drug); Comparator: placebo (unspecified) (Drug); Enalapril (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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

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

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

Secondary outcome: 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.

Eligibility

Minimum age: 35 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: October 2007
Last updated: October 29, 2014

Page last updated: August 23, 2015

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