Clinical trial NCT00783263: A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
timeFrame: Baseline to 6 weeks
measure: Number of Participants Who Reached Their Target LDL-C Level
timeFrame: 6 weeks of treatment
measure: Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
timeFrame: 6 weeks of treatment
measure: Number of Participants Who Reached the LDL-C Level of <70 mg/dl
timeFrame: 6 weeks of treatment
measure: Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
timeFrame: 6 weeks of treatment
measure: Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.