drugset / Trial / NCT00309777

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

NCT00309777 ↗

Phase 3 Completed 857 enrolled Kowa Research Europe
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Timeline

Start
2005-09
Primary completion
2006-10
Completion
2006-10

Outcome

Met primary endpoint

paper Pitavastatin 2 mg showed significantly better reductions of LDL-C (p = 0.014) PMID 19785568 ↗

paper Pitavastatin was considered superior to simvastatin in terms of percent reduction of LDL-C in the lower dose group comparison PMID 19785568 ↗

paper proved to be equivalent to simvastatin in percent reduction of LDL-C in the higher-dose group. PMID 19785568 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pitavastatin Small molecule 2 mg —
Subject Pitavastatin Small molecule 4 mg —
Comparator Simvastatin Small molecule 20 mg —
Comparator Simvastatin Small molecule 40 mg —

Indications