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A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients Wit...

Update Il y a 5 ans
Reference: EUCTR2007-005839-28

A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease: Evaluation of plasma anacetrapib concentrations, lipid levels and pregnancy outcomes (women of child-bearing potential) in patients who were previously treated with anacetrapib

Woman and Man

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Extract

PN019-00 to 04: Evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo on plasma concentrations of LDL-C. PN019-10 and 11: To assess the safety and tolerability of anacetrapib 100 mg PN019-12 and 14: (1) To assess the plasma levels of anacetrapib during the reversal period and to estimate the apparent terminal half-life (t1/2) of anacetrapib (2) To assess the safety and tolerability during the 1-year reversal period following cessation of anacetrapib PN019-06: To assess the plasma levels of anacetrapib remaining in patients who were previously treated with anacetrapib

Inclusion criteria

  • Hypercholesterolemia, mixed hyperlipidemia

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