drugset / Trial / NCT02799758

Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

NCT02799758

Phase 3 Withdrawn Kowa Research Institute, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment

Timeline

Start
2016-02
Primary completion
2017-07
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Livalo® IR Unknown 4 mg Oral
Subject NK-104-CR Unknown 8 mg Oral

Indications