Trials / Completed
CompletedNCT01966601
A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 620 (actual)
- Sponsor
- Trevena Inc. · Industry
- Sex
- All
- Age
- 21 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TRV027 Dose #1 | TRV027 continuous intravenous infusion Dose #1 |
| DRUG | TRV027 Dose #2 | TRV027 continuous intravenous infusion Dose #2 |
| DRUG | TRV027 Dose #3 | TRV027 continuous intravenous infusion Dose #3 |
| DRUG | Placebo | Placebo continuous intravenous infusion |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-03-01
- Completion
- 2016-09-01
- First posted
- 2013-10-21
- Last updated
- 2018-07-26
Locations
62 sites across 12 countries: United States, Argentina, Bulgaria, Canada, Czechia, Germany, Hungary, Israel, Poland, Romania, Russia, Slovakia
Source: ClinicalTrials.gov record NCT01966601. Inclusion in this directory is not an endorsement.