Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT00319267
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2006-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bosentan in Children With Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'Italy', 'Netherlands', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2006-04-26', 'studyFirstSubmitQcDate': '2006-04-26', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'description': 'AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours .'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of bosentan and its metabolites', 'timeFrame': 'At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose', 'description': 'Maximum observed plasma concentration for bosentan and its metabolites was directly derived from their respective plasma concentration-time curves.'}, {'measure': 'Time to reach the maximum plasma concentration (tmax) of bosentan and its metabolites', 'timeFrame': 'At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose'}, {'measure': 'Area under the plasma concentration-time curve during a dose interval (AUCt) for the metabolites of bosentan', 'timeFrame': 'At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose', 'description': 'AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours.'}]}, 'conditionsModule': {'keywords': ['bosentan', 'children', 'pharmacokinetics', 'pulmonary arterial hypertension'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '20002090', 'type': 'RESULT', 'citation': 'Beghetti M, Haworth SG, Bonnet D, Barst RJ, Acar P, Fraisse A, Ivy DD, Jais X, Schulze-Neick I, Galie N, Morganti A, Dingemanse J, Kusic-Pajic A, Berger RM. Pharmacokinetic and clinical profile of a novel formulation of bosentan in children with pulmonary arterial hypertension: the FUTURE-1 study. Br J Clin Pharmacol. 2009 Dec;68(6):948-55. doi: 10.1111/j.1365-2125.2009.03532.x.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent by the parents or the legal representatives.\n* Males or females \\>= 2 and \\< 12 years of age.\n* Idiopathic PAH or familial PAH diagnosed by right heart catheterization (Clinical classification of pulmonary hypertension, Venice 2003).\n* World Health Organization (WHO) functional class II or III.\n* Oxygen saturation (SpO2) \\>= 88% (at rest, on room air).\n* PAH treatment-naïve patients or patients already treated with either:\n\n * Bosentan monotherapy\n * Intravenous epoprostenol monotherapy\n * Intravenous or inhaled iloprost monotherapy\n * Combination of bosentan and intravenous epoprostenol\n * Combination of bosentan and intravenous or inhaled iloprost.\n* 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.\n* PAH therapy stable for at least 3 months prior to Screening.\n* Stable treatment with calcium channel blockers, if any, for at least 3 months prior to Screening.\n* Patient's PAH condition stable for at least 3 months prior to Screening.\n\nExclusion Criteria:\n\n* PAH associated with conditions other than idiopathic or familial PAH.\n* 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.\n* Need or plan to wean patients from intravenous epoprostenol, or intravenous, or inhaled iloprost.\n* Body weight \\< 4 kg.\n* Systolic blood pressure \\< 80%, the lower limit of normal range, according to age and gender.\n* AST and/or ALT values \\> 3 times the upper limit of normal ranges.\n* Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.\n* Hemoglobin and/or hematocrit levels \\< 75% of the lower limit of normal ranges.\n* Pregnancy.\n* Known intolerance or hypersensitivity to bosentan or any of the excipients."}, 'identificationModule': {'nctId': 'NCT00319267', 'acronym': 'FUTURE-1', 'briefTitle': 'Bosentan in Children With Pulmonary Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'AC-052-365'}, 'secondaryIdInfos': [{'id': '2004-005157-63', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bosentan', 'description': 'The initial dose of bosentan was 2 mg/kg b.i.d. for 4 weeks. After 4 weeks, the initial dose was up-titrated to the maintenance dose of 4 mg/kg b.i.d. up to the end of the study treatment at Week 12. If the maintenance dose was not well tolerated, the dose could be down-titrated to the initial dose.', 'interventionNames': ['Drug: Bosentan']}], 'interventions': [{'name': 'Bosentan', 'type': 'DRUG', 'otherNames': ['ACT-050088', 'Ro 47-0203'], 'description': 'Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets', 'armGroupLabels': ['Bosentan']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}