Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol … (NCT00319449) | Clinical Trial Compass
CompletedPhase 4
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
22 participantsStarted 2005-09
Plain-language summary
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have an LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation.
* Participants must have triglyceride concentrations of \< 3.99 mmol/L (350 mg/dL).
* Participants must have two or more coronary heart disease risk factors listed below:
* Current cigarette smoking
* Hypertension (BP \>= 140/90 mmHg or on antihypertensive medication)
* Low HDL cholesterol (\< 40 mg/dL)
* Family history of premature CHD (CHD in male first degree relative \< 55 years; CHD in female first degree relative \< 65 years)
* Age (Men \>= 45 years; women \>= 55 years)
* Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating.
* Participants must have liver transaminases (ALT, AST) \< 50% above the upper limit of normal, with no active liver disease, and CK \< 50% above the upper limit of normal.
* Participants must have maintained a cholesterol lowering diet, exercise program, and stable weight for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study.
* Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study.
Exclusion Criteria:
* Partici…
What they're measuring
1
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg