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

Primary Purpose

Pulmonary Arterial Hypertension

Status
No longer available
Phase
Locations
Brazil
Study Type
Expanded Access
Intervention
sildenafil (Revatio) 20 mg TID
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Pulmonary Arterial Hypertension focused on measuring Open label, sildenafil, PAH, Brazil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 20, 2009
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00866983
Brief Title
Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
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.
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Open label, sildenafil, PAH, Brazil

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sildenafil (Revatio) 20 mg TID
Other Intervention Name(s)
sildenafil, Revatio
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04012-909
Country
Brazil

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481270&StudyName=Local%20Open-Label%20Access%20Study%20For%20Patients%20Who%20Completed%20A1481244%20Study%20In%20Brazil
Description
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Learn more about this trial

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

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