Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety



Status:Terminated
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:16 - 80
Updated:10/27/2018
Start Date:July 2010
End Date:January 2011

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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

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
pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in
combination.


Inclusion Criteria:

- Previously enrolled in B1321001 for at least 4 weeks.

- Previously enrolled in B1321003, discontinued from the study.

- Completed the B1321003 study as planned.

Exclusion Criteria:

- Treated with an investigational drug (other than sitaxsentan or sildenafil in either
B1321001 or B1321003) or device that has not received regulatory approval within the
30 days prior to Baseline/Day 1 or during the study.
We found this trial at
2
sites
Fountain Valley, California 92708
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Fountain Valley, CA
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Cluj Napoca, 40000
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Cluj Napoca,
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