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EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension (EXPERT)

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: NCT02092818
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Riociguat (Adempas, BAY63-2521)

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Study Type : Observational
Actual Enrollment : 1316 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Actual Study Start Date : May 31, 2014
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Group/Cohort Intervention/treatment
Group 1
Patients who have been prescribed Adempas for a medically appropriate use
Drug: Riociguat (Adempas, BAY63-2521)
The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Up to 4 years ]
  2. Number of serious adverse events [ Time Frame: Up to 4 years ]
  3. All-cause mortality [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) [ Time Frame: Up to 4 years ]
  2. Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH) [ Time Frame: Up to 4 years ]
  3. Incidence of AE of special interest overall [ Time Frame: Up to 4 years ]
  4. Incidence of AE of special interest in different PH indications (PAH, CTEPH) [ Time Frame: Up to 4 years ]
  5. 6 minute walking distance [ Time Frame: Up to 4 years ]
  6. Functional class of pulmonary hypertension according to NYHA/ WHO [ Time Frame: Up to 4 years ]
    NYHA/ WHO: New York Heart Association / World Health Organization

  7. Borg Dyspnoea Index [ Time Frame: Up to 4 years ]
  8. EQ5D visual analogue scale (VAS) score [ Time Frame: Up to 4 years ]
    EQ5D: EurQuol 5 dimensions (questionnaire)

  9. Number of patients with hemodynamic measurements [ Time Frame: Up to 4 years ]
  10. Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP)) [ Time Frame: Up to 4 years ]
  11. Number of hospitalization [ Time Frame: Up to 4 years ]
  12. Number of outpatient visits [ Time Frame: Up to 4 years ]
  13. Number of days in home care [ Time Frame: Up to 4 years ]
  14. Number of days in rehabilitation [ Time Frame: Up to 4 years ]
  15. Number of days in nursery home [ Time Frame: Up to 4 years ]
  16. Drug treatment for PH [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have been prescribed Adempas® for a medically appropriate use
Criteria

Inclusion Criteria:

  • Female and male patients who start or are on treatment with Adempas
  • Written informed consent

Exclusion Criteria:

  • Patients currently participating in an interventional clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092818


Locations
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Argentina
Multiple Locations, Argentina
Australia
Multiple Locations, Australia
Austria
Multiple Locations, Austria
Belgium
Multiple Locations, Belgium
Canada
Multiple Locations, Canada
Colombia
Multiple Locations, Colombia
Czechia
Multiple Locations, Czechia
Denmark
Multiple Locations, Denmark
Estonia
Multiple Locations, Estonia
Finland
Multiple Locations, Finland
France
Multiple Locations, France
Germany
Multiple Locations, Germany
Greece
Multiple Locations, Greece
Ireland
Multiple Locations, Ireland
Italy
Multiple Locations, Italy
Luxembourg
Multiple Locations, Luxembourg
Netherlands
Multiple Locations, Netherlands
Norway
Multiple Locations, Norway
Portugal
Multiple Locations, Portugal
Russian Federation
Multiple Locations, Russian Federation
Saudi Arabia
Multiple Locations, Saudi Arabia
Slovakia
Multiple Locations, Slovakia
Spain
Multiple Locations, Spain
Sweden
Multiple Locations, Sweden
Switzerland
Multiple Locations, Switzerland
Taiwan
Multiple Locations, Taiwan
Turkey
Multiple Locations, Turkey
United Kingdom
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02092818    
Other Study ID Numbers: 16657
AD1301 ( Other Identifier: company internal )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action