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

Last updated on November 9, 2019

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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.
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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.
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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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Descriptive Information
Brief TitleTo Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
Official TitleA 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationExpanded access
ConditionPulmonary Hypertension
Intervention
  • Drug: sildenafil
    tablets, 20mg, TID, 112 weeks at the maximum
  • Drug: sildenafil
    tablets, 20mg x 4 (80mg), TID, approximately 70 weeks
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 29, 2010)
32
Original EnrollmentNot Provided
Actual Study Completion DateMarch 2009
Actual Primary Completion DateMarch 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesPoland
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00946114
Other Study ID NumbersA1481242
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2013

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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