Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01644331 · ClinicalTrials.gov registry record · Phase 3
Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
A Phase 3 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 257
- Enrollment target
NCT01644331: Completed Phase 3 study, sponsored by Duke University.
NCT01644331 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 257 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644331, a Phase 3 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 257 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone
Primary Outcome
The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.
Interventions
- DRUG Placebo
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT01644331 record still lists
NCT01644331 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01644331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01644331 about?
NCT01644331 is a clinical study titled "Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure". The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute decompensated heart failure The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be m...
What is the current status of trial NCT01644331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 257 participants. The study started on 2012-10. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01644331?
The interventions under investigation include: Placebo (DRUG), Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT01644331?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644331's enrollment target sits among peer trials
257 1238th of 2000 higher than 761 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03618550 · 257 participants · Phase 2
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
- NCT04674267 · 257 participants · NA
Resilience and Equity in Aging, Cancer, and Health (REACH)
- NCT06099288 · 257 participants · NA
Strong Families Start at Home/Familias Fuertes Comienzan en Casa
- NCT06207084 · 257 participants · NA
The Fit With Us Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia