Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005856

Trial Description

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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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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)

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005856
  •   2015/02/19
  •   2014/01/02
  •   no
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Secondary IDs

  •   NCT02060721  (ClinicalTrials.gov)
  •   AC-055E202  (Actelion)
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Health Condition or Problem studied

  •   Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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Interventions/Observational Groups

  •   Drug: Macitentan
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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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.

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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.

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Countries of Recruitment

  •   United States
  •   Austria
  •   Belgium
  •   Bulgaria
  •   Canada
  •   Chile
  •   China
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Mexico
  •   Netherlands
  •   Poland
  •   Russian Federation
  •   South Africa
  •   Switzerland
  •   Thailand
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   78
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study
as scheduled (i.e., who remained in the DB study up to Week 24).

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Exclusion Criteria

- Permanent discontinuation of DB study treatment due to an hepatic adverse event or
liver aminotransferase abnormalities.

- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable
psychiatric illness) that, in the opinion of the investigator, may interfere with
treatment compliance or interpretation of the results, or that may influence the
ability to comply with any of the study requirements.

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Addresses

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    • Actelion
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.