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THERAPY-HYBRID-BPA Trial

NCT04600492 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-10-23

No results posted yet for this study

Summary

Riociguat could improve the exercise capacity and residual symptoms in patients with chronic thromboembolic pulmonary hypertension (CTEPH) even after normalization of pulmonary arterial pressure by balloon pulmonary angioplasty (BPA). This randomized controlled trial study aimed to clarify whether the improvement of peak cardiac index (CI) during exercise maintains or not between the riociguat continued group and the riociguat discontinued group.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Riociguat Oral Tablet

Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo

Sponsors & Collaborators

  • Bayer Yakuhin, Ltd.

    collaborator INDUSTRY

  • National Hospital Organization Okayama Medical Center

    lead OTHER

Principal Investigators

  • Yutaka Ito · National Hospital Organization Nagoya Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2023-09-30
Completion
2025-01-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600492 on ClinicalTrials.gov