Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651014
• Other study ID #: P03405
• Status: Terminated
• Phase: Phase 4
• Start date: January 2004
• Est. completion date: June 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe
oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
• Placebo
oral tablet; ezetimibe placebo once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Merck Frosst Canada Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.		6 weeks
Secondary	Percent change from baseline to endpoint in LDL-C.		6 weeks
Secondary	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.		6 weeks
Secondary	Safety/tolerability: adverse events, laboratory test results, vital signs.		Throughout study