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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

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE April 19, 2011
Results First Submitted Date  ICMJE September 20, 2017
Results First Posted Date  ICMJE December 11, 2017
Last Update Posted Date December 11, 2017
Actual Study Start Date  ICMJE March 8, 2011
Actual Primary Completion Date August 13, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 7 days after study drug discontinuation ]
Treatment-emergent AEs and SAEs up to 7 days after permanent discontinuation of study drug. No primary endpoint has been defined for this open-label, exploratory extension study. 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).
Change History Complete list of historical versions of study NCT01338415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
  • Adverse Events (AEs) leading to premature discontinuation of study drug [ Time Frame: Baseline to permanent discontinuation of study drug ]
    Adverse events (AEs) leading to premature discontinuation of study drug
  • Changes in vital signs, body weight, and height/length [ Time Frame: Baseline to end of study ]
    Changes in vital signs, body weight, and height/length
Current Other Pre-specified Outcome Measures
 (submitted: November 9, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FUTURE 3 Study Extension
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Bosentan
  • 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
    Intervention: Drug: Bosentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2017)
58
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2011)
64
Actual Study Completion Date  ICMJE August 13, 2014
Actual Primary Completion Date August 13, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belarus,   China,   Czechia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01338415
Other Study ID Numbers  ICMJE AC-052-374
2010-021793-12 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Actelion
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP