Trial Condition(s):
Hypertension, Pulmonary
EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT)
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Belgium | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Czech Republic | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Australia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Portugal | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Austria | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Greece | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Slovakia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Switzerland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Sweden | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Denmark | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Norway | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Finland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Luxembourg | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Saudi Arabia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Locations, Estonia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Many Location, Canada | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
Primary Outcome
- Number of adverse eventsTimeframe: Up to 4 years
- Number of serious adverse eventsTimeframe: Up to 4 years
- All-cause mortalityTimeframe: Up to 4 years
Secondary Outcome
- Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)Timeframe: Up to 4 years
- Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)Timeframe: Up to 4 years
- Incidence of AE of special interest overallTimeframe: Up to 4 years
- Incidence of AE of special interest in different PH indications (PAH, CTEPH)Timeframe: Up to 4 years
- 6 minute walking distanceTimeframe: Up to 4 years
- Functional class of pulmonary hypertension according to NYHA/ WHONYHA/ WHO: New York Heart Association / World Health OrganizationTimeframe: Up to 4 years
- Borg Dyspnoea IndexTimeframe: Up to 4 years
- EQ5D visual analogue scale (VAS) scoreEQ5D: EurQuol 5 dimensions (questionnaire)Timeframe: Up to 4 years
- Number of patients with hemodynamic measurementsTimeframe: Up to 4 years
- Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))Timeframe: Up to 4 years
- Number of hospitalizationTimeframe: Up to 4 years
- Number of outpatient visitsTimeframe: Up to 4 years
- Number of days in home careTimeframe: Up to 4 years
- Number of days in rehabilitationTimeframe: Up to 4 years
- Number of days in nursery homeTimeframe: Up to 4 years
- Drug treatment for PHTimeframe: Up to 4 years
Additional Information
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