Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 8, 2011

Primary Completion Date

April 3, 2013

Study Completion Date

August 19, 2013

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

bosentan

32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY