Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03273257
Status:
TERMINATED
Last Update Posted:
2021-06-22
First Post:
2017-08-25
Brief Title:
Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy PEA Bridging Study
Sponsor:
International CTEPH Association
Organization:
International CTEPH Association
Study Overview
Official Title:
A Phase 2 Randomised Double-Blind Placebo-Controlled Multicentre Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic both of which made study completion within a reasonable timeframe appear unlikely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None