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MK8141

Phase 2

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Oct 16, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00543413A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)PHASE2 COMPLETED 160Oct 1, 2007Jun 1, 2008Oct 16, 2015 -
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALArm 1: Drug 250 mg
2EXPERIMENTALArm 2: Drug 500 mg
3ACTIVE_COMPARATORArm 3: Active Comparator
4PLACEBO_COMPARATORArm 4: Pbo Comparator
Interventions
NameTypeDescription
MK8141DRUGMK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Comparator: placebo (unspecified)DRUGMK8141 Pbo tablet once daily. 4 week treatment period.
EnalaprilDRUGEnalapril 20 mg tablet once daily. 4 week treatment period.
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Eligibility Criteria
Age Range35 Years — 65 Years
SexALL
Healthy VolunteersNo

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 Exclusio...

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