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NCT Number: NCT00543413

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK8141

Drug

MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period

Comparator: Placebo (Unspecified)

Drug

MK8141 Pbo tablet once daily. 4 week treatment period.

Enalapril

Drug

Enalapril 20 mg tablet once daily. 4 week treatment period.

Other names: Vasotec®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Actelion

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2007
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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