Status:

COMPLETED

A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Lead Sponsor:

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

Conditions:

Pulmonary Arterial Hypertension

Eligibility:

All Genders

1-17 years

Phase:

PHASE3

Brief Summary

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

Eligibility Criteria

Inclusion

  • Patients must complete the 16 Week double-blind efficacy study A1481131.

Exclusion

  • Any patient who did not complete Study A1481131.

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

234 Patients enrolled

Trial Details

Trial ID

NCT00159874

Start Date

January 1 2004

End Date

December 1 2012

Last Update

February 1 2021

Active Locations (39)

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Page 1 of 10 (39 locations)

1

Pfizer Investigational Site

Palo Alto, California, United States, 34304

2

Pfizer Investigational Site

Palo Alto, California, United States, 94305

3

Pfizer Investigational Site

Stanford, California, United States, 94305

4

Pfizer Investigational Site

Aurora, Colorado, United States, 80045