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FUTURE 3 Study Extension

NCT01338415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-03-30

Study results available
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Summary

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

Conditions

Interventions

DRUG

Bosentan

Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NON_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
2014-08-13
Completion
2020-05-29

Countries

  • United States
  • Australia
  • Belarus
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01338415 on ClinicalTrials.gov