We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    EXPERT - Exposure registry Riociguat in patients with pulmonary hypertension
Previous Study | Return to List | Next Study

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
Information provided by (Responsible Party):

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)

Layout table for study information
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.

Layout table for eligibility information
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

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

Layout table for location information
Multiple Locations, Argentina
Multiple Locations, Australia
Multiple Locations, Austria
Multiple Locations, Belgium
Multiple Locations, Canada
Multiple Locations, Colombia
Multiple Locations, Czechia
Multiple Locations, Denmark
Multiple Locations, Estonia
Multiple Locations, Finland
Multiple Locations, France
Multiple Locations, Germany
Multiple Locations, Greece
Multiple Locations, Ireland
Multiple Locations, Italy
Multiple Locations, Luxembourg
Multiple Locations, Netherlands
Multiple Locations, Norway
Multiple Locations, Portugal
Russian Federation
Multiple Locations, Russian Federation
Saudi Arabia
Multiple Locations, Saudi Arabia
Multiple Locations, Slovakia
Multiple Locations, Spain
Multiple Locations, Sweden
Multiple Locations, Switzerland
Multiple Locations, Taiwan
Multiple Locations, Turkey
United Kingdom
Multiple Locations, United Kingdom
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Additional Information:
Layout table for additonal information
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:
Layout table for MeSH terms
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action