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Sandostatin LAR Depot

Phase 2

Primary Insulin Hypersecretion | Small molecule | Metabolic |Novartis AG|Last Updated: Sep 22, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00094146Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate ObesityPHASE2 COMPLETED 160 — — Jan 1, 2002Dec 1, 2002Sep 22, 20093 United States
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Study Endpoints
Primary Endpoints
The percent change at baseline compared to 6 months in body weight
Secondary Endpoints
Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Sandostatin LAR DepotDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: You may qualify for this study if you: * are between the ages of 18-70 (male or female) * are at least moderately obese (BMI \> 30 kg/m2 or approximately 30 or more pounds overweight) * and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces to...

Countries:United States
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