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

NCT ID: NCT00783263

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-05-31

Brief Summary

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comparator: rosuvastatin 5 mg + ezetimibe 10 mg

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Comparator: rosuvastatin 10 mg

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Comparator: rosuvastatin 10 mg + ezetimibe 10 mg

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Comparator: rosuvastatin 20 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Crestor, Zetia; Crestor; Crestor, Zetia; Crestor

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.

Reference Type: RESULT

PMID: 21596364 (View on PubMed)

Other Identifiers

2008_567

Identifier Type: -

Identifier Source: secondary_id

0653-139

Identifier Type: -

Identifier Source: org_study_id