Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor
NCT ID: NCT02007629
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2014-02-18
2016-12-29
Brief Summary
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Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Riociguat
Subjects received riociguat film coated immediate-release (IR) tablet 3 times a day (tid) with or without food at a starting dose of 1.0 milligram (mg) and increased by 0.5 mg increments at 2-weekly intervals to a maximum of 2.5 mg tid, until Week 8 (titration phase). An optimal dose was determined based on systolic blood pressure (SBP) and well-being. Thereafter, riociguat continued at the optimal individual dose until Week 24 (Main phase). Dose reductions or stop of study medication for safety reasons were allowed at any time. Increases or re-increases in 0.5 mg steps (maximum dose 2.5 mg) were possible at the investigator's discretion weighing the benefit with potential risks implied. Subjects were offered participation in EDSP and received riociguat 2.5 mg film coated IR tablet 3 tid with or without food for 18 months or until reimbursement.
Riociguat (Adempas, BAY63-2521)
Riociguat / BAY63-2521 film-coated tablets will be used in this study at a dosage of either 0.5, 1.0, 1.5, 2.0, and 2.5 mg. 3 times daily
Interventions
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Riociguat (Adempas, BAY63-2521)
Riociguat / BAY63-2521 film-coated tablets will be used in this study at a dosage of either 0.5, 1.0, 1.5, 2.0, and 2.5 mg. 3 times daily
Eligibility Criteria
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Inclusion Criteria
* Patients with and without endothelin receptor antagonist (ERA) therapy
* World Health Organization Functional Class (WHO FC) III at screening
* 6-minute walking distance (6MWD) of 165-440 m
* Cardiac index \<3.0 L/min/m\*2.
* Evidence of clinically significant restrictive or obstructive parenchymal lung diseases
* Diffusing capacity of the lung for carbon monoxide (DLCO) \<30% predicted
* History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
* Patients unable to perform a valid 6MWD test
* Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study.
18 Years
75 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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La Jolla, California, United States
Sacramento, California, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Montreal, Quebec, Canada
Prague, , Czechia
Grenoble, , France
Le Kremlin-Bicêtre, , France
Marseille, , France
Heidelberg, Baden-Wurttemberg, Germany
Regensburg, Bavaria, Germany
Hanover, Lower Saxony, Germany
Cologne, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Rome, Lazio, Italy
Pavia, Lombardy, Italy
Zurich, , Switzerland
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Clydebank, West Dunbartonshire, United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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References
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Hoeper MM, Klinger JR, Benza RL, Simonneau G, Langleben D, Naeije R, Corris PA. Rationale and study design of RESPITE: An open-label, phase 3b study of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors. Respir Med. 2017 Jan;122 Suppl 1:S18-S22. doi: 10.1016/j.rmed.2016.11.001. Epub 2016 Nov 5.
Hoeper MM, Simonneau G, Corris PA, Ghofrani HA, Klinger JR, Langleben D, Naeije R, Jansa P, Rosenkranz S, Scelsi L, Grunig E, Vizza CD, Chang M, Colorado P, Meier C, Busse D, Benza RL. RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. Eur Respir J. 2017 Sep 9;50(3):1602425. doi: 10.1183/13993003.02425-2016. Print 2017 Sep.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2013-001759-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16719
Identifier Type: -
Identifier Source: org_study_id
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