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
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