A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00783263

Purpose

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg Drug: Comparator: rosuvastatin 10 mg Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg Drug: Comparator: rosuvastatin 20 mg	Phase III

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 Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

Secondary Outcome Measures:

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Number of Participants Who Reached Their Target LDL-C Level [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.
Number of Participants Who Reached the LDL-C Level of <70 mg/dl [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.

Enrollment:	440
Study Start Date:	November 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rosuvastatin 5 mg + Ezetimibe 10 mg Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.	Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. Other Name: Crestor, Zetia
Active Comparator: Rosuvastatin 10 mg Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.	Drug: Comparator: rosuvastatin 10 mg Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. Other Name: Crestor
Experimental: Rosuvastatin 10 mg + Ezetimibe 10 mg Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.	Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. Other Name: Crestor, Zetia
Active Comparator: Rosuvastatin 20 mg Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.	Drug: Comparator: rosuvastatin 20 mg Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks. Other Name: Crestor

Eligibility

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

Criteria

Inclusion Criteria:

Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)

Exclusion Criteria:

Participant weighs less than 100 lbs (45 kg).
Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
If female, participant is pregnant or breastfeeding.
Participant consumes more than 2 alcoholic beverages per day.
Participant has been in a clinical trial within the last 30 days.
Participant has heart problems such as CHF, unstable angina or heart attack.
Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
Participant has liver disease.
Participant is Human Immunodeficiency Virus (HIV) positive.
Participant has a history of drug or alcohol abuse in the last year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783263

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

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

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00783263 History of Changes
Other Study ID Numbers:	MK-0653-139, 2008_567
Study First Received:	October 30, 2008
Results First Received:	August 10, 2011
Last Updated:	August 10, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Disease
Hypercholesterolemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin

Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012