Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007236

Trial Description

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Title

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

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Trial Acronym

EXPERT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In accordance with the regulatory guidance this registry has been designed to collect
information about the long-term safety of Adempas in real clinical practice outside the
regulated environment of a controlled clinical study.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007236
  •   2015/05/07
  •   2014/03/19
  •   no
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Secondary IDs

  •   NCT02092818  (ClinicalTrials.gov)
  •   16657  (Bayer)
  •   AD1301 
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Health Condition or Problem studied

  •   Hypertension, Pulmonary
  •   I27 -  Other pulmonary heart diseases
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Interventions/Observational Groups

  •   Drug: Riociguat(BAY63-2521)
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Number of adverse events/ serious adverse events; time frame: Up to 4 years
- all-cause mortality; time frame: Up to 4 years

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Secondary Outcome

- Number of adverse event (AE) and serious adverse event(SAE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH); time frame: Up to 4 years
- 6 minute walking tes; time frame: Up to 4 years
- Number of hospitalization/outpatient visits; time frame: Up to 4 years

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   China
  •   Colombia
  •   Czech Republic
  •   Germany
  •   Greece
  •   Ireland
  •   Israel
  •   Italy
  •   Kazakhstan
  •   Korea, Republic of
  •   Luxembourg
  •   Mexico
  •   Netherlands
  •   Portugal
  •   Russian Federation
  •   Singapore
  •   Slovakia
  •   Spain
  •   Switzerland
  •   Taiwan, Province of China
  •   Turkey
  •   Ukraine
  •   United Arab Emirates
  •   United Kingdom
  •   Venezuela, Bolivarian Republic of
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/05/31
  •   900
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Female and male patients who start or are on treatment with Adempas

- Written informed consent

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Exclusion Criteria

- Patients currently participating in an interventional clinical trial

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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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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    •   [---]*
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Status

  •   Recruiting ongoing
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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
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.