check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

16657

ClinicalTrials.gov Identifier:

NCT02092818

EudraCT Number:

Not Available

EU CT Number:

Not Available
EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension

Trial 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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Female and male patients who start or are on treatment with Adempas
    - Written informed consent

  • - Patients currently participating in an interventional clinical trial

Trial summary

Enrollment Goal
1316
Trial Dates
May 2014 - June 2018
Phase
N/A
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Withdrawn
Many Locations, Mexico
Completed
Many Locations, Czech Republic
Withdrawn
Many Locations, Israel
Completed
Many Locations, Australia
Completed
Many Locations, Portugal
Completed
Many Locations, Argentina
Completed
Many Locations, Austria
Completed
Many Locations, Turkey
Completed
Many Locations, Colombia
Completed
Many Locations, Greece
Withdrawn
Many Locations, Brazil
Completed
Many Locations, Russia
Completed
Many Locations, Slovakia
Withdrawn
Many Locations, Ukraine
Withdrawn
Many Locations, China
Withdrawn
Many Locations, Korea, Republic Of
Completed
Many Locations, Switzerland
Completed
Many Locations, Taiwan
Withdrawn
Many Locations, Venezuela
Withdrawn
Many Locations, Singapore
Completed
Many Locations, Ireland
Withdrawn
Many Locations, Kazakhstan
Withdrawn
Many Locations, United Arab Emirates
Completed
Many Locations, Sweden
Completed
Many Locations, Denmark
Completed
Many Locations, Norway
Completed
Many Locations, Finland
Completed
Many Locations, Luxembourg
Withdrawn
Many Locations, Slovenia
Completed
Many Locations, Saudi Arabia
Withdrawn
Many Locations, Oman
Completed
Many Locations, France
Completed
Many Locations, Estonia
Completed
Many Location, Canada

Primary Outcome

  • Number of adverse events
    date_rangeTime Frame:
    Up to 4 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of serious adverse events
    date_rangeTime Frame:
    Up to 4 years
  • All-cause mortality
    date_rangeTime Frame:
    Up to 4 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
    date_rangeTime Frame:
    Up to 4 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
    date_rangeTime Frame:
    Up to 4 years
  • Incidence of AE of special interest overall
    date_rangeTime Frame:
    Up to 4 years
  • Incidence of AE of special interest in different PH indications (PAH, CTEPH)
    date_rangeTime Frame:
    Up to 4 years
  • 6 minute walking distance
    date_rangeTime Frame:
    Up to 4 years
    enhanced_encryption
    Safety Issue:
    No
  • Functional class of pulmonary hypertension according to NYHA/ WHO
    NYHA/ WHO: New York Heart Association / World Health Organization
    date_rangeTime Frame:
    Up to 4 years
  • Borg Dyspnoea Index
    date_rangeTime Frame:
    Up to 4 years
  • EQ5D visual analogue scale (VAS) score
    EQ5D: EurQuol 5 dimensions (questionnaire)
    date_rangeTime Frame:
    Up to 4 years
  • Number of patients with hemodynamic measurements
    date_rangeTime Frame:
    Up to 4 years
  • Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
    date_rangeTime Frame:
    Up to 4 years
  • Number of hospitalization
    date_rangeTime Frame:
    Up to 4 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of outpatient visits
    date_rangeTime Frame:
    Up to 4 years
  • Number of days in home care
    date_rangeTime Frame:
    Up to 4 years
  • Number of days in rehabilitation
    date_rangeTime Frame:
    Up to 4 years
  • Number of days in nursery home
    date_rangeTime Frame:
    Up to 4 years
  • Drug treatment for PH
    date_rangeTime Frame:
    Up to 4 years

Trial design

EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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