A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia - 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 patients 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

evaluate the LDL-C lowering efficacy [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the LDL-C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin 5 mg compared with rosuvastatin 10 mg [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
To evaluate the LDL-C lowering efficacy of the additional of ezetimibe (10 mg) to rosuvastatin 10 mg compared with rosuvastatin 20 mg [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The percentage of patients treated with rosuvastatin 5 mg or 10 mg alone achieving LDL-C levels recommended by NCEP/ATP III either by adding ezetimibe or doubling rosuvastatin dose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To assess the lipid, lipoprotein, apolipoprotein and high-sensitivity C-reactive protein (hs-CRP) altering effects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	November 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental rosuvastatin 5 mg + ezetimibe 10 mg	Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg Patient will receive open label rosuvastatin 5mg tablets once daily for 6 weeks then receive 10mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
2: Active Comparator rosuvastatin 10 mg	Drug: Comparator: rosuvastatin 10 mg Patients will receive rosuvastatin 5mg tablets once daily for 6 weeks then receive rosuvastatin 10mg once daily for 6 additional weeks.
3: Experimental rosuvastatin 10 mg + ezetimibe 10 mg	Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg Patient will receive open label rosuvastatin 10 mg tablets once daily for 6 weeks then receive 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
4: Active Comparator rosuvastatin 20 mg	Drug: Comparator: rosuvastatin 20 mg Patients will receive rosuvastatin 10 mg tablets once daily for 6 weeks then receive rosuvastatin 20 mg once daily for 6 additional 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 stable dose of lipid lowering agent(s) (if applicable) or is statin naive
Patient is at least moderate high risk for CHD
Patient is willing to maintain TLC/ADA diet

Exclusion Criteria:

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 22 Study Locations

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 Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_567, MK0653-139
Study First Received:	October 30, 2008
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00783263 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
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 February 08, 2010