Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00866983
First received: March 20, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: sildenafil (Revatio) 20 mg TID
Phase 4

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sildenafil (Revatio) 20 mg TID
    To provide access to sildenafil for patients completing the A1481244 study, resides in Brazilian States where Revatio™ is not supplied by Health Secretary and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil. It will be supplied until the patient gets access to Sildenafil through Brazilian State Health Secretary from where the patient resides.
    Other Name: sildenafil, Revatio
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject who completed the A1481244 study and are judged by the Investigator to derive clinical benefit from continuous treatment with Sildenafil 20 mg therapy.
  • Subject who resides in a Brazilian State where Sildenafil is not supplied by State Health Secretary.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Current participation in other studies and during study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866983

Locations
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 04012-909
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00866983     History of Changes
Other Study ID Numbers: A1481270
Study First Received: March 20, 2009
Last Updated: February 11, 2013
Health Authority: Brazil: National Ethics Committee (CONEP)

Keywords provided by Pfizer:
Open label
sildenafil
PAH
Brazil

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014