check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

16719

ClinicalTrials.gov Identifier:

NCT02007629

EudraCT Number:

2013-001759-10

EU CT Number:

Not Available
Riociguat clinical Effects Studied in Patients with Insufficient Treatment response to phosphodiesterase-5 inhibitor

Trial purpose

BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat.
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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated PAH due to congenital heart disease (Group I / Dana Point Classification of PH) demonstrating insufficient response to treatment with PDE-5i for at least 3 months
    - 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.
  • - All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria
    - 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.

Trial summary

Enrollment Goal
61
Trial Dates
February 2014 - December 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hannover, 30625, Germany
Withdrawn
Gießen, 35392, Germany
Completed
Dresden, 01307, Germany
Completed
Leipzig, 04103, Germany
Completed
Heidelberg, 69126, Germany
Completed
Köln, 50924, Germany
Completed
LE KREMLIN BICETRE CEDEX, 94275, France
Withdrawn
Aurora, 80045, United States
Completed
Pittsburgh, 15212, United States
Withdrawn
Boston, 02118, United States
Completed
Providence, 02903, United States
Completed
St, Louis, 63110, United States
Withdrawn
Los Angeles, 90073, United States
Completed
Zürich, 8091, Switzerland
Withdrawn
Lausanne, 1011, Switzerland
Completed
Boston, 02111, United States
Completed
Iowa City, 52242-1089, United States
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
LEUVEN, 3000, Belgium
Completed
Praha 2, 12808, Czech Republic
Completed
Sacramento, 95817, United States
Completed
Pavia, 27100, Italy
Completed
Roma, 00161, Italy
Completed
Montreal, H3T 1E2, Canada
Withdrawn
Torrance, 90502, United States
Completed
Regensburg, 93053, Germany
Completed
GRENOBLE Cedex 09, 38043, France
Completed
La Jolla, 92093, United States
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Clydebank, G81 4DY, United Kingdom
Completed
London, NW3 2QG, United Kingdom
Completed
MARSEILLE, 13005, France
Terminated
London, SW3 6NP, United Kingdom

Primary Outcome

  • Change from baseline in 6 Minute Walking Distance (6MWD)
    6MWD test was used to measure the subjects functional exercise capacity. Subjects were instructed to walk alone, not run, from one end to the other end of the walking course, at their own pace, while attempting to cover as much ground as possible in 6 minutes. No “warm-up” period was performed before the test. Investigators have not walked with the subjects. This was an encouraged test (the person conducting the test encouraged subjects to walk farther or faster by using only standardized phrases).
    date_rangeTime Frame:
    Baseline, Week 12 and Week 24
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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