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Aliskiren

Phase 1

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Jan 22, 2016

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00856960The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)PHASE1 COMPLETED 12Jan 1, 2010Apr 1, 2010Jan 22, 2016 -
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Study Endpoints
Primary Endpoints
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
2-5 hours post dose of study drug
Secondary Endpoints
change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
2-5 hours post dose of study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORAliskiren 600 mg
2ACTIVE_COMPARATORAliskiren 150 mg
3ACTIVE_COMPARATORLosartan 100 mg
4PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AliskirenDRUGSingle dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.
Comparator: LosartanDRUGSingle dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to AliskirenDRUGThree or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to LosartanDRUGSingle dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is in generally good health * Subject is willing to avoid unaccustomed strenuous exercise during the study * Subject agrees to consume ONLY the study-specified diet during all domiciled periods * Subject has been a non-smoker for at least 3 months prior to study * Subj...

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