Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

NCT01982292 ↗

Phase 2 Completed 321 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blind

Summary

The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

Timeline

Start: 2014-05
Primary completion: 2015-09
Completion: 2015-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); RLX030 (Serelaxin) vs Placebo; p >0.9999; Difference in percentage 0.50 (90% CI -9.38 to 10.38); Fisher Exact NCT01982292 ↗

Publications

Kumar VA, Wilson SS, Ayaz SI, Levy PD. Targeted biological therapies reach the heart: the case of serelaxin for heart failure. Drugs Today (Barc). 2015 Oct;51(10):591-7. doi: 10.1358/dot.2015.51.10.2386731.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Serelaxin	Protein / enzyme biologic	30 ug/kg	Intravenous