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

Study Overview
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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.

Official Title
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A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: sildenafil
* Drug: sildenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization. Subjects whose baseline 6-min walk test distance was > 100m and < 450m. Exclusion Criteria: PAH secondary to any etiology other than those specified in the inclusion criteria. Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sildenafil|tablets, 20mg, TID, 112 weeks at the maximum|
|Drug: sildenafil|tablets, 20mg x 4 (80mg), TID, approximately 70 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. | Baseline up to 116 Weeks |