Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Ato… (NCT00651378) | Clinical Trial Compass
TerminatedPhase 4
Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of \<2.5 mmol/L. Treatment phase is 6 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 18 years to 75 years of age;
* Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at least 80% of daily doses for the 4 weeks preceding Visit 1;
* LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160 mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1, using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until data analysis);
* Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on blood specimens taken at Visit 1;
* Documented atherosclerotic disease, CHD, or diabetes mellitus;
* Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no active liver disease, and CPK less than 50% above the upper limit of normal as tested in blood specimens taken at Visit 1;
* Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must have been within normal limits or clinically acceptable to the Investigator;
* Had been previously prescribed a cholesterol lowering diet and exercise program at least 4 weeks prior to Visit 1 and had been advised to continue the same diet and exercise program during the study;
* Reported a stable weight history for at least 4 weeks prior to randomization at Visit 3 (baseline visit);
* Women receiving hormonal therapy, including hormone replacement, any estrog…
What they're measuring
1
Percent change in LDL-C level from baseline to the study endpoint.