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

This study has been terminated.

( slow subject recruitment and lack of medical and scientific merit due to change in new standard of therapy during that same period. )

First Received: March 31, 2008 Last Updated: April 1, 2008 History of Changes

Sponsors and Collaborators:	Schering-Plough Merck Frosst Canada Ltd.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00651014

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Atherosclerosis	Drug: Ezetimibe Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Percentage of patients reaching LDL-C goal of < 2.5 mmol/L (97 mg/dL) at endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to endpoint in LDL-C. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Safety/tolerability: adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	82
Study Start Date:	January 2004
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03405
Study First Received:	March 31, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00651014 History of Changes
Health Authority:	Canada: HPFB (Health Protection and Food Branch)

Study placed in the following topic categories:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Vascular Diseases
Ezetimibe

Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Diabetes Mellitus, Type 2
Metabolic Disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009