Pulmonary Arterial Hypertension in Children (FUTURE 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01223352
First received: October 12, 2010
Last updated: October 9, 2013
Last verified: October 2013

October 12, 2010
October 9, 2013
January 2011
August 2013   (final data collection date for primary outcome measure)
Daily exposure to bosentan (AUC over 24 hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Daily exposure to bosentan, i.e., AUC over a period of 24 h (AUC0-24h), and calculated as a multiple of the exposure over a dosing interval (AUCτ), 3 × AUCτ and 2 × AUCτ for three times and two times daily dosing, respectively.
Same as current
Complete list of historical versions of study NCT01223352 on ClinicalTrials.gov Archive Site
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Pulmonary Arterial Hypertension in Children
An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

The AC-052-373 study is a PK phase III study to compare two dosing regimen of the pediatric bosentan formulation as well as efficacy and safety in children with Pulmonary Arterial Hypertension (PAH) <12 years of age.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: bosentan
    bosentan 2mg/kg b.i.d.
  • Drug: bosentan
    bosentan 2mg/kg t.i.d.
  • Experimental: Arm 2
    bosentan 2 mg/kg t.i.d.
    Intervention: Drug: bosentan
  • Experimental: Arm 1
    bosentan 2mg/kg b.i.d.
    Intervention: Drug: bosentan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. PAH diagnosis confirmed with right heart catheterization (RHC):

    • Idiopathic or heritable PAH, or
    • Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery)
  2. WHO functional Class I, II or III
  3. Male or female ≥ 3 months and < 12 years of age (maximum age at randomization is 11.5 years)
  4. Body weight ≥3,5 kg
  5. Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air)
  6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, PDE-5 inhibitor) if present, has to be stable for at least 3 months prior to screening During the study, all background treatments should remain stable
  7. Signed informed consent by the parents or legal representatives

Exclusion Criteria:

  1. PAH etiologies other than listed above
  2. Non-stable disease status
  3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost
  4. Systolic blood pressure < 80% of the lower limit of normal range
  5. AST and/or ALT values > 1.5 times the upper limit of normal range.
  6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
  8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet
  9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:

    • Glibenclamide (glyburide)
    • Cyclosporin A
    • Sirolimus
    • Tacrolimus
    • Fluconazole
    • Rifampicin (rifampin)
    • Ritonavir
    • Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
    • Endothelin receptor antagonists (ERAs) other than bosentan
  10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment
Both
3 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belarus,   China,   Czech Republic,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine
 
NCT01223352
AC-052-373
Not Provided
Actelion
Actelion
Not Provided
Not Provided
Actelion
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP