Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
Public ClinicalTrials.gov record NCT00034307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.
Study identification
- NCT ID
- NCT00034307
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jun 24, 2005
United States locations
- U.S. sites
- 25
- U.S. states
- 19
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California Hospital, Ambulatory Health Sciences | Los Angeles | California | 90033 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| The Children's Hospital | Denver | Colorado | 80218 | — |
| University of Colorado/ Health Science Center | Denver | Colorado | 80262 | — |
| Emory University Hospital - McKelvey Lung Transplantation Center | Atlanta | Georgia | 30322 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| Dekalb Medical Center | Decatur | Georgia | 30033 | — |
| Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | — |
| LSU - School of Medicine | New Orleans | Louisiana | 70112 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| John Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Hospital, Division of Cardiology | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic - Division of Cardiovascular Disease | Rochester | Minnesota | 55905 | — |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| The Cleveland Clinic Foundation, Department of Pulmonary and Critical Care | Cleveland | Ohio | 44195 | — |
| Division of Cardiology - The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Oregon Health Sciences | Portland | Oregon | 97201 | — |
| University of Pittsburgh Medical Center, CHF/Transplantation Cardiology | Pittsburgh | Pennsylvania | 15213 | — |
| Pulmonary Division - Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor College of Medicine Pulmonary & Critical Care Section | Houston | Texas | 77030 | — |
| University of Wisconsin Medical School | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00034307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2005 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00034307 live on ClinicalTrials.gov.