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Trial record 1 of 5 for:    Bosentan, actelion, FUTURE
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Bosentan in Children With Pulmonary Arterial Hypertension Extension Study (FUTURE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00319020
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : March 29, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE April 26, 2006
First Posted Date  ICMJE April 27, 2006
Results First Submitted Date  ICMJE February 9, 2017
Results First Posted Date  ICMJE March 29, 2017
Last Update Posted Date June 14, 2017
Actual Study Start Date  ICMJE August 23, 2005
Actual Primary Completion Date October 28, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • Change From Baseline to End of Study (EOS) in Height for Age. [ Time Frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average ]
    In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula: Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population
  • Change From Baseline to End of Study (EOS) in Body Weight [ Time Frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height.
  • Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP) [ Time Frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.
  • Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP) [ Time Frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.
  • Change From Baseline to End of Study (EOS) in Pulse Rate [ Time Frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate.
  • Proportion of Patients With Treatment-emergent Liver Function Abnormalities [ Time Frame: After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes. Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here.
  • Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities [ Time Frame: After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average ]
    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities. Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here.
  • Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment [ Time Frame: From the first study drug administration in FUTURE 1, for an average of 31 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Treatment-emergent adverse events up to 24 hours after permanent discontinuation of study drug
  • Adverse events leading to premature discontinuation of study drug
  • Serious adverse events up to 28 days after permanent discontinuation of study drug
  • Changes from Baseline to Study End in vital signs, body weight, and height
  • Treatment-emergent marked laboratory abnormalities
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
Change from Baseline in FUTURE 1 to Study End or Premature study drug discontinuation in WHO functional class, quality of life questionnaire, Global Clinical Impression scale according to parents/legal guardians and physician
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Official Title  ICMJE An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1
Brief Summary The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: Bosentan
32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally
Other Names:
  • Ro 47-0203
  • Tracleer
Study Arms  ICMJE Experimental: Bosentan
Bosentan was administered at 4 mg/kg twice daily (b.i.d.) until the end of the study. It could be down-titrated to 2 mg/kg b.i.d. if not well tolerated.
Intervention: Drug: Bosentan
Publications * Berger RM, Haworth SG, Bonnet D, Dulac Y, Fraisse A, Galiè N, Ivy DD, Jaïs X, Miera O, Rosenzweig EB, Efficace M, Kusic-Pajic A, Beghetti M. FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion. Int J Cardiol. 2016 Jan 1;202:52-8. doi: 10.1016/j.ijcard.2015.08.080. Epub 2015 Aug 9. Erratum in: Int J Cardiol. 2016 Nov 15;223:1072-1073.

*   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: April 8, 2013)
33
Original Enrollment  ICMJE
 (submitted: April 26, 2006)
30
Actual Study Completion Date  ICMJE October 28, 2011
Actual Primary Completion Date October 28, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent by the parents or the legal representatives.
  • Patients who completed the FUTURE 1 study.
  • Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
  • Males or females >= 2 and < 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.

Exclusion Criteria:

  • Intolerance to bosentan despite dose reductions.
  • Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
  • Pregnancy or breast-feeding.
  • Known hypersensitivity to bosentan or any of the excipients.
  • Premature and permanent study drug discontinuation during FUTURE 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Netherlands,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319020
Other Study ID Numbers  ICMJE AC-052-367
2005-001967-70 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andjela Kusic-Pajic, MD Actelion
PRS Account Actelion
Verification Date May 2017

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