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

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ClinicalTrials.gov Identifier: NCT02092818
Recruitment Status : Active, not recruiting
First Posted : March 20, 2014
Last Update Posted : May 14, 2018
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(BAY63-2521)

Study Type : Observational
Actual Enrollment : 1353 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
Estimated Primary Completion Date : June 19, 2018
Estimated Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat
U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



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

Secondary Outcome Measures :
  1. 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 ]
  2. 6 minute walking test [ Time Frame: Up to 4 years ]
  3. Number of hospitalization/outpatient visits [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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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

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


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02092818     History of Changes
Other Study ID Numbers: 16657
AD1301 ( Other Identifier: company internal )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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