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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	8 February 2021
Main ID:	NCT00866983
Date of registration:	20/03/2009
Prospective Registration:	No
Primary sponsor:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Public title:	Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
Scientific 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.
Date of first enrolment:	October 2008
Target sample size:
Recruitment status:	No longer available
URL:	https://clinicaltrials.gov/show/NCT00866983
Study type:	Expanded Access
Study design:
Phase:

Countries of recruitment
Brazil

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: sildenafil (Revatio) 20 mg TID

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

A1481270

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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