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

March 20, 2009
February 11, 2013
October 2009
September 2012   (final data collection date for primary outcome measure)
Not Provided
To provide access to sildenafil for patients completing the A1481244 study [ Time Frame: Unknown ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00866983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
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.

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.

Not Provided
Expanded Access
Phase 4
Not Provided
Pulmonary Arterial Hypertension
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00866983
A1481270
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP