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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00946114
First received: July 22, 2009
Last updated: February 12, 2013
Last verified: February 2013

July 22, 2009
February 12, 2013
June 2006
March 2009   (final data collection date for primary outcome measure)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 116 Weeks ] [ Designated as safety issue: Yes ]
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.
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Complete list of historical versions of study NCT00946114 on ClinicalTrials.gov Archive Site
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To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
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.

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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Expanded access

Pulmonary Hypertension
  • Drug: sildenafil
    tablets, 20mg, TID, 112 weeks at the maximum
  • Drug: sildenafil
    tablets, 20mg x 4 (80mg), TID, approximately 70 weeks
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2009
March 2009   (final data collection date for primary outcome measure)

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.

Exclusion Criteria:

  1. PAH secondary to any etiology other than those specified in the inclusion criteria.
  2. 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.
  3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00946114
A1481242
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP