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NCT00435591 · ClinicalTrials.gov registry record · Phase 4
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
A Phase 4 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT00435591: Completed Phase 4 study, sponsored by Cumberland Pharmaceuticals.
NCT00435591 is a Phase 4 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 121 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435591, a Phase 4 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
Primary Outcome
Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant \& represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thr
Interventions
- DRUG placebo
- DRUG Conivaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-09 |
| Phase | Phase 4 |
What the finished NCT00435591 record still lists
NCT00435591 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00435591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00435591 about?
NCT00435591 is a clinical study titled "A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia". The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
What is the current status of trial NCT00435591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2007-01. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00435591?
The interventions under investigation include: placebo (DRUG), Conivaptan (DRUG).
Who is sponsoring clinical trial NCT00435591?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00435591's enrollment target sits among peer trials
121 669th of 2000 higher than 1,328 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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