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

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543413
First received: October 5, 2007
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: MK8141
Drug: Comparator: placebo (unspecified)
Drug: Enalapril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vasotec®
Placebo Comparator: 4
Arm 4: Pbo Comparator
Drug: Comparator: placebo (unspecified)
MK8141 Pbo tablet once daily. 4 week treatment period.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543413

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Actelion
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543413     History of Changes
Other Study ID Numbers: 8141-006, MK8141-006, 2007_587
Study First Received: October 5, 2007
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014