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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 on March 31, 2008.   Last Updated on April 1, 2008   History of Changes
Sponsor: Schering-Plough
Collaborator: 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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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: 6q24-related transient neonatal diabetes mellitus hypercholesterolemia
MedlinePlus related topics: Atherosclerosis Cholesterol Coronary Artery Disease Heart Diseases
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
Experimental: Ezetimibe Drug: Ezetimibe
oral tablet; ezetimibe 10 mg once daily for 6 weeks (added to ongoing simvastatin 10 or 20 mg once daily)
Other Names:
  • SCH 58235
  • Zetia
Placebo Comparator: Placebo 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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00651014     History of Changes
Other Study ID Numbers: P03405
Study First Received: March 31, 2008
Last Updated: April 1, 2008
Health Authority: Canada: HPFB (Health Protection and Food Branch)

Additional relevant MeSH terms:
Atherosclerosis
Coronary Disease
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012



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