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

NCT00946114 | Completed Results

• 1 other identifier: A1481242
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

sildenafil DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Expanded access

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (2)

Pfizer Investigational Site

Warsaw, 01-138, Poland

Location

Pfizer Investigational Site

Zabrze, 41-800, Poland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: June 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 1, 2021
• Results First Posted: March 30, 2010

Record last verified: 2021-01

Locations

PL (2)