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

NCT00651014 | Terminated Phase 4 DMC

• 1 other identifier: P03405
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Hypercholesterolemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint.

  6 weeks

Secondary Outcomes (3)

• Percent change from baseline to endpoint in LDL-C.

  6 weeks

• 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

• Safety/tolerability: adverse events, laboratory test results, vital signs.

  Throughout study

Study Arms (2)

Ezetimibe

EXPERIMENTAL

Drug: Ezetimibe

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ezetimibe DRUG

oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)

Also known as: SCH 58235, Zetia

Ezetimibe

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead
• Merck Frosst Canada Ltd.: collaborator

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: January 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: February 17, 2022

Record last verified: 2022-02