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COMPLETED Phase 2

A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

NCT00303498 · View on ClinicalTrials.gov ↗

Study Summary

The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Sitexsentin sodium

Study Locations (20)

California

  • University of Southern California Medical Center — Los Angeles
  • Orange County Heart Institute and Research Center — Orange
  • Sacramento Heart & Vascular Medical Associates — Sacramento
  • University of California — San Diego

Alabama

  • University of Alabama at Birmingham — Birmingham
  • Mobile Heart Specialists, PC — Mobile
  • Preventative and Research Cardiloogy Providence Hospital — Mobile

Arizona

  • Arizona Pulmonary Specialists, LTD — Phoenix
  • Parkview Research Center — Tucson
  • Southwest Heart — Tucson

Illinois

  • The University of Chicago — Chicago
  • Methodist Medical Center — Peoria

Massachusetts

  • Massachusetts General Hospital Pulmonary and Critical Care Unit — Boston
  • Brigham and Women's Hospital — Boston

Alaska

  • Central Arkansas Veterans HCS — Little Rock

Arkansas

  • University of Arkansas for Medical Services/Cardiology Department — Little Rock

Connecticut

  • Yale University School of Medicine, Cardiovascular Medicine — New Haven

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2006-03-27
Est. Completion 2008-05-01
Phase Phase 2

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00303498

The ClinicalTrials.gov registry entry for NCT00303498 describes a study currently listed as completed. It is categorized as Phase 2, 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 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diastolic Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT00303498 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 NCT00303498 about?

NCT00303498 is a clinical study titled "A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure". The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.

What is the current status of trial NCT00303498?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2006-03-27. Estimated completion is 2008-05-01.

What conditions does trial NCT00303498 study?

This clinical trial studies the following conditions: Diastolic 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 NCT00303498?

The interventions under investigation include: Placebo (DRUG), Sitexsentin sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00303498?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00303498 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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