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Trial record 26 of 66 for:    "Lung Disease" | "Bosentan"

FUTURE 3 Study Extension (FUTURE 3 Ext)

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ClinicalTrials.gov Identifier: NCT01338415
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Bosentan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
Actual Study Start Date : March 8, 2011
Actual Primary Completion Date : August 13, 2014
Actual Study Completion Date : August 13, 2014


Arm Intervention/treatment
Experimental: bosentan 2mg/kg b.i.d.
Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Drug: Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Other Name: ACT-050088

Experimental: bosentan 2mg/kg t.i.d.
Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Drug: Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Other Name: ACT-050088




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation [ Time Frame: Up to 62 weeks in average ]

    This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study.

    NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.



Other Outcome Measures:
  1. Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) [ Time Frame: At Month 12 ]
    The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.

  2. Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) [ Time Frame: At Month 18 ]
    The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.

  3. Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) [ Time Frame: At Month 12 ]
    The GCIS is a scale used to rate the patient's current overall clinical condition ("Very Good", "Good", "Neither Good or Bad", "Bad", and "Very Bad"). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.

  4. Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) [ Time Frame: At Month 18 ]
    The GCIS is a scale used to rate the patient's current overall clinical condition ("Very Good", "Good", "Neither Good or Bad", "Bad", and "Very Bad"). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.

  5. Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days [ Time Frame: Up to 62 weeks in average ]
    Number of patients with at least one PAH-worsening component (death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH, new/worsening right heart failure) reported cumulatively over FUTURE 3 core and extension study.

  6. Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days [ Time Frame: From baseline to Month 18 ]
    PAH progression was defined by time elapsed from the first study drug administration in the FUTURE core study to the day of the first occurrence of any of the following PAH worsening events: death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH or new / worsening right heart failure. Subjects without a PAH worsening event were censored at EOT + 7 days. PAH progression was estimated by Kaplan-Meier methodology and expressed by the percentage of participants free of events at different time points.

  7. Overall Survival [ Time Frame: From baseline to month 18 ]
    Overall survival was defined as the time elapsed between the first study drug administration and death (any cause) up to end of study (Month 18 survival follow-up), regardless of whether the patient was on study treatment. Patients who died, regardless of the cause of death, were considered to have had an event.Patients last known to have been alive were censored on their date of last contact. Percentage of participants without death at different time points was estimated using Kaplan-Meier methodology.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued
  2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
  3. Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.

Exclusion Criteria:

  1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet
  2. Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy
  3. Pregnancy
  4. AST and/or ALT values > 3 times the upper limit of normal range (ULN)
  5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  6. Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
  7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338415


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Sponsors and Collaborators
Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01338415     History of Changes
Other Study ID Numbers: AC-052-374
2010-021793-12 ( EudraCT Number )
First Posted: April 19, 2011    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: November 2017
Keywords provided by Actelion:
pediatric
pulmonary arterial hypertension
bosentan
Tracleer
Additional relevant MeSH terms:
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Lung Diseases
Bosentan
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action