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
3 other identifiers
interventional
160
0 countries
N/A
Brief Summary
This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Oct 2007
Shorter than P25 for phase_2 hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 16, 2015
October 1, 2015
8 months
October 5, 2007
October 15, 2015
Conditions
Outcome Measures
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.
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.
after 4 weeks of treatment
Study Arms (4)
1
EXPERIMENTALArm 1: Drug 250 mg
2
EXPERIMENTALArm 2: Drug 500 mg
3
ACTIVE COMPARATORArm 3: Active Comparator
4
PLACEBO COMPARATORArm 4: Pbo Comparator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Actelioncollaborator
Related Publications (1)
Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P. Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension. J Am Soc Hypertens. 2010 Sep-Oct;4(5):219-26. doi: 10.1016/j.jash.2010.06.006. Epub 2010 Aug 12.
PMID: 20705534RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 15, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
October 16, 2015
Record last verified: 2015-10