Status:
COMPLETED
Lipid Efficacy/Tolerability Study (0524A-020)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Primary Hypercholesterolaemia
Mixed Hyperlipidaemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and ...
Eligibility Criteria
Inclusion
- Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
- Have medical conditions considered to be CHD equivalent).
- LDL-C below 130 mg/dL for patients with multiple risk factors.
- LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides \</= to 350 mg/dL.
Exclusion
- A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients \< 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
- Pregnant or lactating women, or women intending to become pregnant are excluded.
- Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
- Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
1620 Patients enrolled
Trial Details
Trial ID
NCT00269204
Start Date
December 1 2005
End Date
December 1 2006
Last Update
July 27 2015
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