Chronic thromboembolic pulmonary hypertension (CTEPH)
Conditions
Sponsors
Nippon Shinyaku Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who have a diagnosis of CTEPH based on 2 or more tests out of pulmonary ventilation/perfusion scan, pulmonary angiography, and chest contrast enhanced CT -Patients with a diagnosis of PH confirmed by right heart catheterization according to the following criteria : Resting mean pulmonary arterial pressure (mPAP) >= 25 mmHg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure 360 dyn sec/cm5 as measured by a screening/baseline right heart catheterization -Patients treated with an anticoagulant at its effective dose defined in the package insert from 90 days before or earlier from the date of baseline measurement until the start of study drug administration
Exclusion criteria
Exclusion criteria: -Patients with severe obstructive lung disease -Patients with severe restrictive pulmonary disease -Patients with acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6-minute walking test), e.g., angina pectoris, intermittent claudication -Patients with acute symptomatic pulmonary embolism within 180 days before the start of study drug administration -Patients with moderate or severe hepatic impairment -Patients with moderate or severe renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy plumonary vascular resistance | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy mean pulmonary arterial pressure | — |
Countries
Japan
Outcome results
None listed