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Ezetimibe

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment1,743

FDA Designations

No designations recorded

Clinical trial landscape

Ezetimibe · 2 trials · 3 indications

Phase 3 2
NCT0052582412-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With EzetimibeHypercholesterolemia
COMPLETED1,743 Analytics
NCT00653445Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mgHypercholesterolemia
COMPLETED- Analytics
PHASE3COMPLETED
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
HypercholesterolemiaUnlock trial analytics

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)
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Ezetimibe

What is Ezetimibe used for?

Ezetimibe is used for hypercholesterolemia, a condition of high cholesterol. It is being studied in combination with rosuvastatin for patients with hypercholesterolemia, coronary heart disease, and atherosclerosis. The drug is in Phase 3 clinical development and is not yet approved.

Who makes Ezetimibe?

Ezetimibe is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting Phase 3 clinical trials for the drug in hypercholesterolemia.

What phase is Ezetimibe in?

Ezetimibe is in Phase 3 clinical development. It is an investigational drug and has not been approved. Two Phase 3 trials have been completed, with a total enrollment of 1,743 participants.

What clinical trials is Ezetimibe in?

Ezetimibe has two completed Phase 3 trials: NCT00525824, a 12-week open-label study comparing rosuvastatin in combination with ezetimibe, enrolling 1,743 patients; and NCT00653445, comparing rosuvastatin 40mg with ezetimibe 10mg. Both studied hypercholesterolemia, coronary heart disease, and atherosclerosis.

How does Ezetimibe work?

Ezetimibe is a small molecule that works by targeting cholesterol absorption in the intestine. It is being studied in combination with rosuvastatin, a statin, to lower cholesterol levels in patients with hypercholesterolemia.