Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00303498 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
A Phase 2 study of Diastolic Heart Failure, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT00303498: Completed Phase 2 study of Diastolic Heart Failure, sponsored by Pfizer.
NCT00303498 is a Phase 2 study of Diastolic Heart Failure that has completed, run by Pfizer. The registered enrollment target is 200 participants, below the 381-participant average among 7 other Diastolic Heart Failure trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00303498, a Phase 2 study of Diastolic Heart Failure, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
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%.
Primary Outcome
Treadmill exercise test is used to assess the functional capacity of participants with cardiac disease. Treadmill exercise test was conducted using the 2 minute incremental Naughton protocol. The Naughton protocol starts with a 2 minute warm-up. The speed of treadmill is set to 1 mile per hour (mph) and the incline is set to 0. After the warm-up, the speed is set at 2 mph for the remainder of the test. The test consists of six, 2 minute intervals. The grade starts at 0 for the first interval, an
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-03-27 |
| Est. Completion | 2008-05-01 |
| Phase | Phase 2 |
What the finished NCT00303498 record still lists
NCT00303498 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 381-participant average among 7 other Diastolic Heart Failure trials with a reported enrollment target (48% lower).
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.
NCT00303498 names 20 study sites across 11 states, led by California, Alabama, Arizona.
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.
What interventions are being tested in trial NCT00303498?
The interventions under investigation include: Placebo (DRUG), Sitexsentin sodium (DRUG).
Who is sponsoring clinical trial NCT00303498?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diastolic Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
COMPLETED · Phase 2
-
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
RECRUITING · Phase 4
-
Purinergic Signaling and the Postmenopausal Heart
RECRUITING
-
Assessment of CCM in HF With Higher Ejection Fraction
RECRUITING · NA
-
Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES
RECRUITING · Phase 1
-
Physiological Effects of Grape Seed Extract in Diastolic Heart Failure
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI