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Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01223352•Actelion

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 12 years

Sex

ALL

Healthy Volunteers

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)
+9 more criteria

Key Dates

Start Date

March 8, 2011

Primary Completion Date

April 3, 2013

Completion Date

August 19, 2013

Last Updated

February 4, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

bosentan

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization