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MK0954, /Duration of Treatment : 5 Years

Phase 3

Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart) | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Feb 15, 2022

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment496
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00338260Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)PHASE3 COMPLETED 496Jun 1, 1995Nov 1, 2001Feb 15, 2022 -
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Study Endpoints
Primary Endpoints
Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)
Secondary Endpoints
cardiovascular death, stroke, myocardial infarction, all-cause mortality, hospitalization for heart failure, new-onset diabetes mellitus
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
MK0954, /Duration of Treatment : 5 YearsDRUG -
Comparator : atenolol /Duration of Treatment : 5 YearsDRUG -
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Eligibility Criteria
Age Range55 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age 55 to 80 years * Males and females * Hypertension (160-200/95-115 mm Hg * ECG evidence of left ventricular hypertrophy Exclusion Criteria: * Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers * ...

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