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

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)

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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