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MK0954, /Duration of Treatment : 16 Weeks

Phase 3

Hypertension | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Aug 15, 2024

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 Enrollment143
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00541684Health Assessment Study (0954-946)PHASE3 COMPLETED 143Jul 11, 2001Jan 23, 2003Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
number of sexual intercourse events in a 2-week period
2 Weeks
Secondary Endpoints
sexual functioning score and overall sexual satisfaction score after 16 weeks
16 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0954, /Duration of Treatment : 16 WeeksDRUG -
Comparator : atenolol /Duration of Treatment : 16 WeeksDRUG -
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Eligibility Criteria
Age Range40 Years — 49 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Newly diagnosed with mild to moderate hypertension\\ * Married male in stable heterosexual relationship * No prior history of sexual dysfunction * Satisfied with overall sex life * Patient's spouse is in close proximity for the study * Has had at least 2 but not more than 10 s...

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