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NCT00525707 · ClinicalTrials.gov registry record · Phase 3

Tezosentan in Acute Heart Failure

A Phase 3 study of Acute Heart Failure and Acute Decompensation of Chronic Heart Failure, sponsored by Idorsia Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
735
Enrollment target
20
Study locations

NCT00525707 is a Phase 3 study of Acute Heart Failure and Acute Decompensation of Chronic Heart Failure that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 735 participants, below the 1,361-participant average among 8 other Acute Heart Failure trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00525707, a Phase 3 study of Acute Heart Failure and Acute Decompensation of Chronic Heart Failure, has completed, sponsored by Idorsia Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
735 participants
Enrollment target
20
Study locations

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

Acute Heart Failure Acute Decompensation of Chronic Heart Failure New Onset of Heart Failure

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

FieldValue
Enrollment Target 735 participants
Start Date 2003-04
Est. Completion 2005-01
Phase Phase 3

Sponsor

Idorsia Pharmaceuticals

34 total trials

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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, categorized as Phase 3. The registered enrollment target is 735 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,361-participant average among 8 other Acute Heart Failure trials with a reported enrollment target (46% lower). The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.

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.

NCT00525707 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Texas, Alabama.

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.

What interventions are being tested in trial NCT00525707?

The interventions under investigation include: tezosentan (DRUG).

Who is sponsoring clinical trial NCT00525707?

This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.