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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg; Drug: Comparator: rosuvastatin 10 mg; Drug: Comparator: rosuvastatin 20 mg; Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783263

0653-139

2008_567

Details and patient eligibility

About

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

Enrollment: 440 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 4 patient groups

Rosuvastatin 5 mg + Ezetimibe 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg

Rosuvastatin 10 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Comparator: rosuvastatin 10 mg

Rosuvastatin 10 mg + Ezetimibe 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg

Rosuvastatin 20 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Comparator: rosuvastatin 20 mg