Woman and Man
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Extract
Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg. Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing LDL-C. Note: For LDL-C primary hypothesis, the criterion for bioequivalence is that the 95% confidence interval (CI) of the difference in percent change from baseline between the two treatments falls within ±4%.
Inclusion criteria
- Primary Hypercholesterolemia & Mixed Dyslipdemia