Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)(TERMINATED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Atherosclerosis
Intervention: Ezetimibe (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Schering-Plough
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 NCEP III guidelines to achieve their LDL-C target goal of <=3. 0 mmol/L.
As this study was to be conducted in Canada, the target LDL-C goal for patients with CHD, or
type II diabetic patients >30 years old with no CHD, was <2. 5 mmol/L.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-Administered With Existing Simvastatin 10mg or 20mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease and/or Type II Diabetes
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.
Secondary outcome: Percent change from baseline to endpoint in LDL-C.Percent change from baseline to endpoint in total cholesterol (TC) triglycerides, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio, and apolipoprotein B. Safety/tolerability: adverse events, laboratory test results, vital signs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- >=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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: January 2004
Ending date: June 2006
Last updated: April 1, 2008
|
