A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00479713

Purpose

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in patients with high cholesterol.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe (+) simvastatin Drug: Comparator : rosuvastatin calcium Drug: Comparator: Placebo (unspecified)	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Cholest-5-en-3-ol (3beta)- Simvastatin Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

Further study details as provided by Merck:

Primary Outcome Measures:

The low density lipoprotein-cholesterol (LDL-C) level after 6 weeks of treatment [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The percentage of patients achieving designated LDL-C levels after 6 weeks of treatment [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	1200
Study Start Date:	March 2007
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: drug	Drug: ezetimibe (+) simvastatin ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks. Drug: Comparator: Placebo (unspecified) rosuvastatin 10mg Pbo. The treatment duration will be 6 weeks.
2: Active Comparator Arm 2: active comparator	Drug: Comparator : rosuvastatin calcium rosuvastatin 10mg. The treatment duration will be 6 weeks. Drug: Comparator: Placebo (unspecified) ezetimibe/simvastatin 10/20mg Pbo. The treatment duration will be 6 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is currently taking a statin medication for the treatment of high cholesterol
Patient has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion Criteria:

Women who are pregnant or nursing, or women who intend to become pregnant
Patient has any condition, situation, or is currently taking any medication that might pose a risk to the patient or interfere with participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479713

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_552, MK0653A-809
Study First Received:	May 24, 2007
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00479713 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Merck:

High Cholesterol

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Calcium, Dietary
Rosuvastatin
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009