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

NCT01223352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-04

Study results available
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Summary

The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.

Conditions

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 & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Andjela Kusic-Pajic, MD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-08
Primary Completion
2013-04-03
Completion
2013-08-19
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223352 on ClinicalTrials.gov