Ezetimibe/Simvastatin in Patients With Metabolic Syndrome - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00409773

Purpose

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Ezetimibe

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 Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Further study details as provided by Merck:

Primary Outcome Measures:

Change in LDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in other lipid parameters [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1120
Study Start Date:	December 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Arm 1: drug + comparator + Pbo	Drug: ezetimibe (+) simvastatin Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: atorvastatin calcium Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: Placebo (unspecified) atorvastatin Pbo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Pbo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
2 Arm 2: drug + comparator + Pbo	Drug: ezetimibe (+) simvastatin Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: atorvastatin calcium Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: Placebo (unspecified) atorvastatin Pbo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Pbo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
3 Arm 3: drug + comparator + Pbo	Drug: ezetimibe (+) simvastatin Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: atorvastatin calcium Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: Placebo (unspecified) atorvastatin Pbo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Pbo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
4 Arm 4: drug + comparator + Pbo	Drug: ezetimibe (+) simvastatin Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: atorvastatin calcium Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: Placebo (unspecified) atorvastatin Pbo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Pbo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
5 Arm 5: drug + comparator + Pbo	Drug: ezetimibe (+) simvastatin Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: atorvastatin calcium Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. Drug: Comparator: Placebo (unspecified) atorvastatin Pbo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Pbo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Pbo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion Criteria:

A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
Patient is likely to be greater than 20% noncompliant in taking study medications
Patients with chronic medical conditions
Patients with unstable doses of medications
Pregnant or lactating women, women intending to become pregnant
Patient is currently receiving prescription therapy with statins or other lipid-altering medications
Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409773

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:	2006_527, MK0653A-107
Study First Received:	December 8, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00409773 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Coronary Disease
Calcium, Dietary
Hypercholesterolemia
Metabolic Disorder
Coronary Artery Disease
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

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

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Syndrome
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009