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NCT02646540 · ClinicalTrials.gov registry record · Phase 1
AiDing Diuresis wIth Tolvaptan (ADD-IT)
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02646540: Completed Phase 1 study, sponsored by Emory University.
NCT02646540 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02646540, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.
Primary Outcome
The number of days hospitalized until discharge.
Interventions
- DRUG Tolvaptan 30 mg + IV Diuretics
- DRUG Metolazone 5 mg + IV Diuretics
- DRUG 2.5 times the Diuretics Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-12-30 |
| Phase | Phase 1 |
What the finished NCT02646540 record still lists
NCT02646540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Tolvaptan 30 mg + IV Diuretics is the first listed.
NCT02646540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02646540 about?
NCT02646540 is a clinical study titled "AiDing Diuresis wIth Tolvaptan (ADD-IT)". The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The i...
What is the current status of trial NCT02646540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-01. Estimated completion is 2018-12-30.
What interventions are being tested in trial NCT02646540?
The interventions under investigation include: Tolvaptan 30 mg + IV Diuretics (DRUG), Metolazone 5 mg + IV Diuretics (DRUG), 2.5 times the Diuretics Dose (DRUG).
Who is sponsoring clinical trial NCT02646540?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02646540's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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