Hypercholesterolemia Clinical Trial
Official title:
A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia, Not Adequately Controlled on Statin Therapy
Primary Objective: To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks. Secondary Objectives: - To evaluate the proportion of patients who attain their LDL-C goal. - To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4. - To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8. - To evaluate the safety of SPC (E10/R10) and R10.
Study duration per participants is approximatively 16 weeks. ;
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