|
|
|
|
|
|
Sponsors and Collaborators: |
ICOS-Texas Biotechnology ICOS Corporation Texas Biotechnology Corporation |
Information provided by: | ICOS-Texas Biotechnology |
ClinicalTrials.gov Identifier: | NCT00034307 |
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.
Condition | Intervention | Phase |
Pulmonary Hypertension |
Drug: sitaxsentan sodium |
Phase II Phase III |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure Pulmonary Hypertension |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension |
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 26 Study Locations |
ICOS-Texas Biotechnology |
ICOS Corporation |
Texas Biotechnology Corporation |
Study Director: | Lyn Frumkin, M.D., Ph.D. | ICOS Corporation |
Pulmonary Hypertension Association 
  |
Study ID Numbers: | FPH01/FPH01-X |
First Received: | April 24, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00034307 |
Health Authority: | United States: Food and Drug Administration |
|
|
|