Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01223352 |
Date of registration:
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12/10/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
FUTURE 3 |
Scientific title:
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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 |
Date of first enrolment:
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March 8, 2011 |
Target sample size:
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64 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01223352 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belarus
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China
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Czech Republic
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Czechia
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France
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Germany
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Hungary
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India
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Israel
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Italy
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Mexico
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Netherlands
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Poland
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Russian Federation
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Serbia
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South Africa
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Spain
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Ukraine
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United States
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Contacts
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Name:
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Andjela Kusic-Pajic, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Actelion |
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Key inclusion & exclusion criteria
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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) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary
shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) 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, 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
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. Aspartate aminotransferase and/or alanine aminotransferase 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
Age minimum:
3 Months
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: bosentan
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Primary Outcome(s)
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Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan
[Time Frame: 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]
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Secondary ID(s)
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AC-052-373
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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