CompletedPhase 3

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

64 participantsStarted 2011-03-08

Plain-language 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.

Who can participate

Age range3 Months – 12 Years

SexALL

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Inclusion criteria

✓. PAH diagnosis confirmed with right heart catheterization (RHC):
✓. World Health Organization functional Class (WHO FC) I, II or III
✓. Male or female ≥ 3 months and \< 12 years of age (maximum age at randomization is 11.5 years)
✓. Body weight ≥ 3.5 kg
✓. Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air)
✓. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-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
✓. Signed informed consent by the parents or legal representatives

Exclusion criteria

✕. PAH etiologies other than listed above
✕. Non-stable disease status
✕. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost
✕. Systolic blood pressure \< 80% of the lower limit of normal range
✕. Aspartate aminotransferase and/or alanine aminotransferase values \> 1.5 times the upper limit of normal range.
✕. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
✕. Hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal range.
✕. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet

What they're measuring

Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan

Timeframe: 0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment

Trial details

NCT IDNCT01223352

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-03

Results submitted2017-03-02

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