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

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ClinicalTrials.gov Identifier: NCT00543413
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: MK8141 Drug: Comparator: placebo (unspecified) Drug: Enalapril Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents