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Tezosentan in Acute Heart Failure
NCT00525707 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG tezosentan
Study Locations (20)
Other
- AKH University of Vienna, Abt. Medizinische Kardiologie — Vienna
- Roskilde Amt Sygehus — Roskilde
- Hopital Ambroise Pare, Service de Cardiologie — Boulogne
- Heart Failure clinic C.H. Dubos — Pontoise
- Hopitaux Universitaires de Strasbourg, Hopital Hautepierre — Strasbourg
- CHU Rangueil, Cardiologie A — Toulouse
- Medizinische Klinik I, Universitatsklinikum Aachen — Aachen
- Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie — Berlin
- Georg-August-Universitat Gottingen, Zentrum fur Innere Med — Göttingen
- Dept. of Cardiology, University of Athens, Alexandra Hospital — Athens
- Barzilai Hospital — Ashkelon
- Carmel Medical Center — Haifa
Texas
- Veterans Affairs Medical Center — Houston
- Tyler Cardiovascular Consultants — Tyler
Alabama
- University of Alabama-Birmingham — Birmingham
California
- Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section — Palo Alto
Colorado
- Denver VAMC — Denver
Pennsylvania
- The Heart Hospital at Alledgheny General, Division of Cardiology — Pittsburgh
Virginia
- Danville Medical Center — Danville
Washington
- Medical Associates, Bellebue — Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 735 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 NCT00525707
The ClinicalTrials.gov registry entry for NCT00525707 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 735 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Acute Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which tezosentan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00525707 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00525707 about?
NCT00525707 is a clinical study titled "Tezosentan in 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 NCT00525707?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 735 participants. The study started on 2003-04. Estimated completion is 2005-01.
What conditions does trial NCT00525707 study?
This clinical trial studies the following conditions: Acute Heart Failure, Acute Decompensation of Chronic Heart Failure, New Onset of Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00525707?
The interventions under investigation include: tezosentan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00525707?
This trial is sponsored by Idorsia Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00525707 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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