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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00796510 |
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for PAH therapy is these two oral drugs administered in combination.
Condition | Intervention | Phase |
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Pulmonary Arterial Hypertension Pulmonary Hypertension PAH |
Drug: Sitaxsentan Drug: Sitaxsentan and Sildenafil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension. |
Estimated Enrollment: | 180 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sitaxsentan: Experimental
Monotherapy arm
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Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
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Sitaxsentan and Sildenafil: Experimental
Combination treatment
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Drug: Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
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Ages Eligible for Study: | 16 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Ohio | |
Pfizer Investigational Site | |
Cincinnati, Ohio, United States, 45219 | |
United States, Texas | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78229 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B1321002, B1321002 |
Study First Received: | November 20, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00796510 |
Health Authority: | United States: Food and Drug Administration |
ETRA
sitaxsentan |
Idiopathic pulmonary hypertension Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Citric Acid Vascular Diseases Sildenafil Hypertension |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |