drugset / Trial / NCT03273257

Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)

NCT03273257

Phase 2 Terminated 14 enrolled International CTEPH Association
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.

Timeline

Start
2018-08-17
Primary completion
2020-05-05
Completion
2020-05-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Riociguat Other / unclassified 2.5 mg