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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:	NCT00878943
Date of registration:	08/04/2009
Prospective Registration:	No
Primary sponsor:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Public title:	Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study UK 92480
Scientific title:	A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.
Date of first enrolment:	March 31, 2009
Target sample size:
Recruitment status:	No longer available
URL:	https://clinicaltrials.gov/show/NCT00878943
Study type:	Expanded Access
Study design:
Phase:

Countries of recruitment
India

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID
therapy.

- All women of childbearing potential must use adequate contraception throughout the
study and four weeks after completion of the study

Exclusion Criteria:

- Pregnant or lactating women

- Participation in other studies during study participation

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with 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 citrate

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

A1481269

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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