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Enteric coated sevelamer

Phase 2

Hypercholesterolemia | Small molecule | Metabolic |Sanofi|Last Updated: Mar 19, 2014

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
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00690937A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate HypercholesteremiaPHASE2 COMPLETED 120Feb 1, 2008Dec 1, 2008Mar 19, 20148 India
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Study Endpoints
Primary Endpoints
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.
throughout study
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).
throughout study
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.
From baseline to Day 42
Secondary Endpoints
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.
From baseline to Day 42
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.
From baseline to Day 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1 ECSEXPERIMENTALLow dose treatment
2 ECSEXPERIMENTALHigh dose treatment
3 ColesevelamACTIVE_COMPARATORActive control treatment
4 PlaceboPLACEBO_COMPARATORPlacebo matched to low dose treatment
5 PlaceboPLACEBO_COMPARATORPlacebo matched to high dose treatment
Interventions
NameTypeDescription
Enteric coated sevelamerDRUGDrug treatment
Colesevelam CholestagelDRUGDrug comparator
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Males and females 18 years of age or older * Clinical diagnosis of mild to moderate hypercholesterolemia 1)LDL cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL 2) Triglycerides less than or equal to 300 mg/dL Exclusion Criteria: * Women who ...

Countries:India
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