Clinical Trial: Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chr

Brief Summary: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Detailed Summary:
Sponsor: Actelion

Current Primary Outcome:

  • Treatment-emergent adverse events (AEs) up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • AEs leading to premature discontinuation of study drug. [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Treatment-emergent serious adverse events up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Change in vital signs (arterial blood pressure, heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 24 months ]


Original Primary Outcome: AEs during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Change from baseline to each scheduled time point in exercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
  • Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
  • Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
  • marked laboratory abnormalities during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
  • Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]


Information By: Actelion

Dates:
Date Received: January 2, 2014
Date Started: February 1, 2015
Date Completion: June 1, 2018
Last Updated: May 16, 2017
Last Verified: May 2017