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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02092818
First received: March 19, 2014
Last updated: July 12, 2017
Last verified: July 2017
  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 ]
  • all-cause mortality [ Time Frame: Up to 4 years ]

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 ]
  • 6 minute walking test [ Time Frame: Up to 4 years ]
  • Number of hospitalization/outpatient visits [ Time Frame: Up to 4 years ]

Enrollment: 1353
Actual Study Start Date: May 31, 2014
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: March 31, 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 protocol (CSP)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
  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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02092818     History of Changes
Other Study ID Numbers: 16657
AD1301 ( Other Identifier: company internal )
Study First Received: March 19, 2014
Last Updated: July 12, 2017

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

ClinicalTrials.gov processed this record on September 25, 2017