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A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally, ...

Update Il y a 4 ans
Reference: EUCTR2004-000139-27

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo, in Subjects With Mixed Dyslipidemia (Frederickson Types IIa and IIb)

Woman and Man

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Extract

The primary objective of this study is to evaluate the LDL C lowering and HDL C elevating efficacy of torcetrapib 60 mg administered in a fixed combination with atorvastatin 10 to 80 mg/day compared to atorvastatin alone or placebo in subjects with mixed dyslipidemia (Frederickson Types IIa and IIb). The LDL-C lowering and HDL-C elevating efficacy of the fixed combination will be tested within and across the 2 types of dyslipidemia to establish its incremental benefit over atorvastatin alone, both across and at each of 4 approved atorvastatin dose levels, and over placebo.

Inclusion criteria

  • Mixed dyslipidemia (Frederickson Types IIa and IIb)

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