To Assess The Safety And Effectiveness Of Ezetimibe Co-Administered With Any Statin Compared To Doubling Of Current Statin Daily Dose In South Asian Canadians - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00664469

Purpose

In South Asian Canadians with documented coronary artery disease or diabetes and hypercholesterolemia with LDL-C levels > 2.0 mmol/L after 4 weeks of monotherapy with any statin: To compare the percent (%) of patients who achieve an LDL-C concentration of >/= 2.0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with any statin at any dose versus doubling of the current statin dose.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe Drug: Simvastatin 20, 40 and 80 mg Drug: Comparator: Atorvastatin Drug: Comparator: Rosuvastatin	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Simvastatin Ezetimibe

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	To Assess The Safety And Effectiveness Of Ezetimibe Co-Administered With Any Statin Compared To Doubling Of Current Statin Daily Dose In South Asian Canadians

Further study details as provided by Merck:

Primary Outcome Measures:

The primary measure of efficacy will be the percentage of patients in each treatment arm achieving a target LDL-C of 2.0 mmol/L at week 6 assessment. [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group 1: Experimental group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.	Drug: ezetimibe ezetimibe 10 mg/day over a 6-week course of treatment. Drug: Simvastatin 20, 40 and 80 mg Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. Drug: Comparator: Atorvastatin Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. Drug: Comparator: Rosuvastatin Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
Group 2: Active Comparator Group 2: patients on statins has their dose doubled for 6 weeks followed by another 6 weeks in which ezetimibe is added or the statin dose is doubled again.	Drug: Simvastatin 20, 40 and 80 mg Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. Drug: Comparator: Atorvastatin Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled. Drug: Comparator: Rosuvastatin Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Arms

Assigned Interventions

group 1: Experimental

group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Drug: ezetimibe

ezetimibe 10 mg/day over a 6-week course of treatment.

Drug: Simvastatin 20, 40 and 80 mg

Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Drug: Comparator: Atorvastatin

Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Drug: Comparator: Rosuvastatin

Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Group 2: Active Comparator

Group 2: patients on statins has their dose doubled for 6 weeks followed by another 6 weeks in which ezetimibe is added or the statin dose is doubled again.

Drug: Simvastatin 20, 40 and 80 mg

Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Drug: Comparator: Atorvastatin

Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Drug: Comparator: Rosuvastatin

Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient Is Of South Asian Descent, Specifically Canadian Citizens Or Landed Immigrants With Ethnic Background From India, Pakistan, Nepal, Bangladesh Or Sri Lanka
Patients With A Diagnosis Of Primary Hypercholesterolemia And Who Are Defined As Being "High Risk" With A Diagnosis Of Cad Or Diabetes, Either By Past Medical History Or By Angiographic Or Laboratory Evidence
The Patient Has Serum Ldl-C > 2.0 Mmol/L While On Any Statin At Below Maximum (10 Mg, 20 Mg Or 40 Mg/Day) Daily Dose For A Minimum Of Four Weeks Prior To The Baseline Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664469

Locations

Canada, Quebec
Merck Frosst Canada Ltd.	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon 514-428-2605

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_006, MK0653-153
Study First Received:	April 1, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00664469
Health Authority:	Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Simvastatin
Ezetimibe

Metabolic disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009