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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Warszawa, , 01-138 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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)

3. Subjects whose baseline 6-min walk test distance was > 100m and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00946114
Pfizer
Completed
To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

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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
Not Provided
Not Provided
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
Not Provided
Not Provided


*   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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00946114
A1481242
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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