Status:
TERMINATED
Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Conditions:
Hypercholesterolemia
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the CHD risk strata of the NCE...
Eligibility Criteria
Inclusion
- \>=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and LDL-C levels of \> 2.5 mmol/L to \<=4.20 mmol/L (97 mg/dL to 160 mg/dL) at Visit 1.
- history of coronary heart disease (type II diabetic patients \> 30 years old with no CHD)
- triglycerides \<= 4.00 mmol/L drawn, and liver transaminases (ALT, AST) \<=50% above the upper limit of normal at Visit 2, with no active liver disease, and/or creatine kinase (CK) \<=50% above the upper limit of normal
Exclusion
- subjects with Body Mass Index \>=35 kg/sqm at Visit 1
- alcohol consumption \> 14 drinks per week
- pregnant or lactating
- treated with any other investigational drug within 30 days prior Visit 1
- previously treated with ezetimibe or participated in a clinical study with ezetimibe
- any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00651014
Start Date
January 1 2004
End Date
June 1 2006
Last Update
February 17 2022
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