CompletedPhase 3

Bosentan in Children With Pulmonary Arterial Hypertension

36 participantsStarted 2005-05

Plain-language summary

The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.

Who can participate

Age range

2 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent by the parents or the legal representatives. * Males or females \>= 2 and \< 12 years of age. * Idiopathic PAH or familial PAH diagnosed by right heart catheterization (Clinical classification of pulmonary hypertension, Venice 2003). * World Health Organization (WHO) functional class II or III. * Oxygen saturation (SpO2) \>= 88% (at rest, on room air). * PAH treatment-naïve patients or patients already treated with either: * Bosentan monotherapy * Intravenous epoprostenol monotherapy * Intravenous or inhaled iloprost monotherapy * Combination of bosentan and intravenous epoprostenol * Combination of bosentan and intravenous or inhaled iloprost. * All patients should start the study drug (bosentan pediatric formulation) at 2 mg/kg twice daily (b.i.d.), whether or not they were previously treated with bosentan. * PAH therapy stable for at least 3 months prior to Screening. * Stable treatment with calcium channel blockers, if any, for at least 3 months prior to Screening. * Patient's PAH condition stable for at least 3 months prior to Screening. Exclusion Criteria: * PAH associated with conditions other than idiopathic or familial PAH. * Non-stable patients, e.g., history (in the last 3 months prior to Screening) of recurrent syncope, or signs and symptoms of non-compensated right heart failure. * Need or plan to wean patients from intravenous epoprostenol, or intravenous, or inhaled iloprost. * Body weight \< 4 kg. * S…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the plasma concentration-time curve during a dose interval (AUCt) for bosentan

Timeframe: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose

Trial details

NCT IDNCT00319267

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials