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

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00783263
• Lead Sponsor: Organon and Co

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2011-05-10
• Disposition First Submitted QC: 2011-05-10
• Disposition First Posted: 2011-05-17
• Results First Submitted: 2011-08-10
• Results First Submitted QC: 2011-08-10
• Results First Posted: 2011-09-14
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment	Baseline to 6 weeks	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

Name	Time	Method
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum	Baseline to 6 weeks	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	6 weeks of treatment	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 Who Reached the LDL-C Level of <70 mg/dl	6 weeks of treatment	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	6 weeks of treatment	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).
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level	6 weeks of treatment	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.
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels	Baseline to 6 weeks	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.