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Megestrol

Phase 3

Anorexia | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 2, 2007

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
Double-BlindUNCONTROLLED
Total Trials2
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002067A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and CachexiaPHASE3 COMPLETED - - -Oct 2, 200714 United States
NCT00002300A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and MalnutritionPHASE2 COMPLETED - - -Oct 2, 200715 United States
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Study Design & Arms
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
Megestrol acetateDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria Patient must have: * Confirmed diagnosis of AIDS (CDC definition). * Documented weight loss or anorexia. * Life expectancy = or \> 20 weeks. * The perception that the weight loss is a detriment to their well-being. * Ability to provide informed consent, read and write English. ...

Countries:United States
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