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NCT01661634 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure
A Phase 3 study of Acute Decompensated Heart Failure, sponsored by Cardiorentis.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,157
- Enrollment target
- 20
- Study locations
NCT01661634: Completed Phase 3 study of Acute Decompensated Heart Failure, sponsored by Cardiorentis.
NCT01661634 is a Phase 3 study of Acute Decompensated Heart Failure that has completed, run by Cardiorentis. The registered enrollment target is 2,157 participants, above the 279-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (673% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01661634, a Phase 3 study of Acute Decompensated Heart Failure, has completed, sponsored by Cardiorentis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,157 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).
Primary Outcome
Improvement in a hierarchical clinical composite comprised of elements associated with: patient global assessment using a 7-point scale of symptomatic improvement, lack of improvement, or worsening; persistent or worsening heart failure (HF) requiring an intervention (initiation or intensification of IV therapy, circulatory or ventilatory mechanical support, surgical intervention, ultrafiltration, hemofiltration or dialysis); and all-cause mortality. Assessment of the clinical composite will be
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ularitide
Study Locations (20)
Michigan
- - Detroit
- - Detroit
- - Detroit
- - Royal Oak
Alabama
- - Huntsville
- - Montgomery
Illinois
- - Peoria
- - Rockford
California
- - Sacramento
Colorado
- - Littleton
Connecticut
- - Trumbull
District of Columbia
- - Washington D.C.
Florida
- - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,157 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
What the finished NCT01661634 record still lists
NCT01661634 is an interventional study that assigns participants to a tested intervention. Its 2,157 participants enrollment target places it among the larger protocols in the corpus, above the 279-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (673% higher).
The record links to 1 condition, with Acute Decompensated Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01661634 names 20 study sites across 15 states, led by Michigan, Alabama, Illinois.
Frequently Asked Questions
What is clinical trial NCT01661634 about?
NCT01661634 is a clinical study titled "Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure". The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).
What is the current status of trial NCT01661634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,157 participants. The study started on 2012-07. Estimated completion is 2016-03.
What conditions does trial NCT01661634 study?
This clinical trial studies the following conditions: Acute Decompensated Heart Failure.
What interventions are being tested in trial NCT01661634?
The interventions under investigation include: Placebo (DRUG), Ularitide (DRUG).
Who is sponsoring clinical trial NCT01661634?
This trial is sponsored by Cardiorentis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01661634 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Decompensated Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01661634's enrollment target sits among peer trials
2,157 1st of 12 higher than 12 of 12 other Acute Decompensated Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Decompensated Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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