Recent Updates
Recently added Catalysts

Ezetimibe

Phase 3

Hypercholesterolemia | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: May 13, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,743
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0052582412-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With EzetimibePHASE3 COMPLETED 1,743Aug 1, 2007Sep 1, 2008May 13, 20119 United States, Argentina +7
NCT00653445Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mgPHASE3 COMPLETED -Jun 1, 2004Jun 1, 2005Mar 26, 2009 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100

To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
Secondary Endpoints
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRosuvastatin 40mg/Ezetimibe 10mg combination therapy
2EXPERIMENTALRosuvastatin 40 mg
Interventions
NameTypeDescription
Rosuvastatin (Crestor)DRUG10mg and 20 mg
EzetimibeDRUG10 mg
SimvastatinDRUG40mg and 80 mg
RosuvastatinDRUG40mg
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of \>20 * Patients will need to sign an informed consent before any visit procedures can be performed, including procedures fo...

Countries:United StatesArgentinaBrazilChileColombiaLithuaniaNetherlandsPeruVenezuela
Unlock Eligibility Criteria