Status:
COMPLETED
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00783263
Start Date
November 1 2008
End Date
May 1 2010
Last Update
May 14 2024
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