Trials / Completed
CompletedNCT01982292
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 321 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RLX030 (serelaxin) | RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours. |
| DRUG | Placebo | Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2013-11-13
- Last updated
- 2016-11-09
- Results posted
- 2016-11-09
Locations
52 sites across 13 countries: United States, Australia, Czechia, Finland, Germany, Italy, Netherlands, Norway, Romania, Russia, Spain, Sweden, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01982292. Inclusion in this directory is not an endorsement.