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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00866983
First Posted: March 23, 2009
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Pulmonary Arterial Hypertension Drug: sildenafil (Revatio) 20 mg TID

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00866983     History of Changes
Other Study ID Numbers: A1481270
First Submitted: March 20, 2009
First Posted: March 23, 2009
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Pfizer:
Open label
sildenafil
PAH
Brazil

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents