Who is sponsoring NCT02799758?

NCT02799758 is sponsored by Kowa Research Institute, Inc..

What condition does NCT02799758 study?

NCT02799758 studies Hyperlipidemia, Dyslipidemia.

What drugs are being tested in NCT02799758?

Interventions: NK-104-CR, Livalo® IR, Placebo (for NK-104-CR), Placebo (for Livalo® IR).

What is the status of NCT02799758?

NCT02799758 is currently WITHDRAWN.

Last reviewed 2021-05-06 · How we verify

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

NCT02799758 Phase 3 WITHDRAWN

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

Details

Lead sponsor	Kowa Research Institute, Inc.
Phase	Phase 3
Status	WITHDRAWN
Start date	2016-02
Completion	2017-11

Conditions

Hyperlipidemia
Dyslipidemia

Interventions

NK-104-CR
Livalo® IR
Placebo (for NK-104-CR)
Placebo (for Livalo® IR)

Primary outcomes

Percent change in Low-density lipoprotein cholesterol (LDL-C) — Baseline to Week 12 endpoint

Countries

United States