A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH)

Phase 3

Completed

• Conditions: Chronic thromboembolic pulmonary hypertension (CTEPH)

• Registration Number: JPRN-jRCT2080223224
• Lead Sponsor: ippon Shinyaku Co., Ltd.

Brief Summary

The result of the examination of efficacy of NS-304 compared with placebo, based on the primary endpoint of PVR, in patients with CTEPH showed that PVR in the NS-304 group significantly decreased compared with that in the placebo group, demonstrating superiority of NS-304 to placebo. Concerning safety, the incidences of headache and diarrhoea were high, but all events were non-serious. There was no clinically significant adverse event, and NS-304 demonstrated favorable tolerability.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-01
• Study Completion: 2022-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 78

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 <= 15 mmHg
-Patients with a baseline pulmonary vascular resistance (PVR) of > 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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>plumonary vascular resistance

Secondary Outcome Measures

Name	Time	Method
efficacy<br>mean pulmonary arterial pressure