EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02092818
First received: March 19, 2014
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention
Hypertension, Pulmonary
Drug: Riociguat(BAY63-2521)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of adverse events/ serious adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
  • all-cause mortality [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 6 minute walking tes [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Number of hospitalization/outpatient visits [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: May 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients who have been prescribed Adempas for a medically appropriate use
Drug: Riociguat(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 report

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092818

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 29 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02092818     History of Changes
Other Study ID Numbers: 16657, AD1301
Study First Received: March 19, 2014
Last Updated: August 8, 2014
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Ethics Committee
Czech Republic: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Greece: Ethics Committee
Ireland: Health Information and Quality Authority
ISREAL: Ethics Commission
Italy: Ethics Committee
Kazakhstan: Ethical Commission
Netherlands: Independent Ethics Committee
Portugal: Data Protection Agency
RUSSIAN FEDERATION: Ethics Committee
Denmark: Centre for Public Health
Norway: Data Protection Authority
Sweden: Institutional Review Board
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Ethikkommission
Turkey: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014