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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00543413
Enrollment
160
Registered
2007-10-15
Start date
2007-10-31
Completion date
2008-06-30
Last updated
2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGEnalapril

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

DRUGMK8141

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

DRUGComparator: placebo (unspecified)

MK8141 Pbo tablet once daily. 4 week treatment period.

Sponsors

Actelion
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
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

Design outcomes

Primary

MeasureTime frame
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.after 4 weeks of treatment

Secondary

MeasureTime frame
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.after 4 weeks of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026