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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 October 19, 2014