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

NCT ID: NCT00866983

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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sildenafil, Revatio

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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A1481270

Identifier Type: -

Identifier Source: org_study_id

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