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NCT03273257 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by International CTEPH Association.

Terminated
Registry status
Phase 2
Development phase
14
Enrollment target

NCT03273257 is a Phase 2 study that was terminated before completion, run by International CTEPH Association. The registered enrollment target is 14 participants.

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The verdict

NCT03273257, a Phase 2 study, was terminated before completion, sponsored by International CTEPH Association.

TERMINATED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Riociguat
  • PROCEDURE Pulmonary endarterectomy

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2018-08-17
Est. Completion 2020-05-05
Phase Phase 2

Sponsor

International CTEPH Association

4 total trials

What the Registry Record Tells You About NCT03273257

The ClinicalTrials.gov registry entry for NCT03273257 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International CTEPH Association, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03273257 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03273257 about?

NCT03273257 is a clinical study titled "Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)". 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 r...

What is the current status of trial NCT03273257?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-08-17. Estimated completion is 2020-05-05.

What interventions are being tested in trial NCT03273257?

The interventions under investigation include: Placebo (DRUG), Riociguat (DRUG), Pulmonary endarterectomy (PROCEDURE).

Who is sponsoring clinical trial NCT03273257?

This trial is sponsored by International CTEPH Association, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.