ClinicalTrials.Veeva

Menu

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

Viatris logo

Viatris

Status and phase

Completed
Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Sildenafil citrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159874
A1481156

Details and patient eligibility

About

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

Enrollment

234 patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Any patient who did not complete Study A1481131.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

234 participants in 3 patient groups

Sildenafil high dose
Experimental group
Description:
As per Protocol Amendment 8 (Aug 2011), all doses in the high dose treatment group were discontinued. Subjects who were receiving these doses and continued in the study were requested to down titrate.
Treatment:
Drug: Sildenafil citrate
Drug: Sildenafil citrate
Drug: Sildenafil citrate
Sildenafil Low dose
Experimental group
Treatment:
Drug: Sildenafil citrate
Drug: Sildenafil citrate
Drug: Sildenafil citrate
Sildenafil medium dose
Experimental group
Description:
As per Protocol Amendment 8 (August 2011), the dose 40 mg TID in the medium dose treatment group was discontinued. Subjects who were receiving this dose and continued in the study were requested to down titrate.
Treatment:
Drug: Sildenafil citrate
Drug: Sildenafil citrate
Drug: Sildenafil citrate

Trial contacts and locations

39

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems