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Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092586
First received: September 23, 2004
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.


Condition Intervention Phase
Hypercholesterolemia
Drug: MK0653, ezetimibe
Drug: Comparator: statins
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent change in LDL-C

Secondary Outcome Measures:
  • Percentage of patients reaching NCEP ATP III target LDL-C levels

Enrollment: 2904
Study Start Date: September 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 6 weeks.

  Eligibility

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

Inclusion Criteria:

  • High cholesterol levels that are identified by specific laboratory values

Exclusion Criteria:

  • Active liver disease
  • Any condition or situation which would interfere with participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092586

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092586     History of Changes
Other Study ID Numbers: 0653-040, 2004_037
Study First Received: September 23, 2004
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014