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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitaxsentan

Monotherapy arm

Group Type EXPERIMENTAL

Sitaxsentan

Intervention Type DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily

Sitaxsentan and Sildenafil

Combination treatment

Group Type EXPERIMENTAL

Sitaxsentan and Sildenafil

Intervention Type DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Interventions

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Sitaxsentan

Sitaxsentan = 100 mg tablet administered orally, once daily

Intervention Type DRUG

Sitaxsentan and Sildenafil

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No