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NCT00524433 · ClinicalTrials.gov registry record · Phase 3
Tezosentan in the Treatment of Acute Heart Failure
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 713
- Enrollment target
NCT00524433 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 713 participants.
The verdict
NCT00524433, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 713 participants
- Enrollment target
Study Summary
The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.
Interventions
- DRUG placebo
- DRUG tezosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2003-04 |
| Est. Completion | 2005-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00524433
The ClinicalTrials.gov registry entry for NCT00524433 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00524433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00524433 about?
NCT00524433 is a clinical study titled "Tezosentan in the Treatment of Acute Heart Failure". The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours ...
What is the current status of trial NCT00524433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 713 participants. The study started on 2003-04. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00524433?
The interventions under investigation include: placebo (DRUG), tezosentan (DRUG).
Who is sponsoring clinical trial NCT00524433?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
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