A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure

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

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

Intervention(s) in this Clinical Trial

• Drug: MK8141
  • MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
• Drug: Comparator: placebo (unspecified)
  • MK8141 Pbo tablet once daily. 4 week treatment period.
• Drug: Enalapril
  • Enalapril 20 mg tablet once daily. 4 week treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug 250 mg
• Experimental: 2
  • Arm 2: Drug 500 mg
• Active Comparator: 3
  • Arm 3: Active Comparator
• Placebo Comparator: 4
  • Arm 4: Pbo Comparator

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00543413

Study ID Number: 2007_587

ClinicalTrials.gov Identifier: NCT00543413

Health Authority: United States: Food and Drug Administration