To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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sildenafil

tablets, 20mg, TID, 112 weeks at the maximum

Intervention Type DRUG

sildenafil

tablets, 20mg x 4 (80mg), TID, approximately 70 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects aged 18 and over who have any of the following conditions:

* Idiopathic pulmonary arterial hypertension.
* PAH associated with connective tissue disease (CTD).
* PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
2. Subjects with a mean pulmonary artery pressure (mPAP) \> 25mmHg and a pulmonary artery wedge pressure (PAWP) \< 15mmHg at rest, assessed via right heart catheterization.
3. Subjects whose baseline 6-min walk test distance was \> 100m and \< 450m.

3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No