Trial Condition(s):

Hypertension, Pulmonary

Riociguat clinical Effects Studied in Patients with Insufficient Treatment response to phosphodiesterase-5 inhibitor (RESPITE)

Bayer Identifier:

16719

ClinicalTrials.gov Identifier:

NCT02007629

EudraCT Number:

2013-001759-10

Study Completed

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.

Inclusion Criteria
-  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.
Exclusion Criteria
- 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
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Dresden, Germany, 01307

Status
Completed
 
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Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
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Heidelberg, Germany, 69126

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
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Investigative Site

LE KREMLIN BICETRE CEDEX, France, 94275

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15212

Status
Completed
 
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Investigative Site

Providence, United States, 02903

Status
Completed
 
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Investigative Site

St, Louis, United States, 63110

Status
Completed
 
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Zürich, Switzerland, 8091

Status
Completed
 
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Investigative Site

Boston, United States, 02111

Status
Completed
 
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Investigative Site

Iowa City, United States, 52242-1089

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
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Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
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Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
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Investigative Site

Sacramento, United States, 95817

Status
Completed
 
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Pavia, Italy, 27100

Status
Completed
 
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Roma, Italy, 00161

Status
Completed
 
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Montreal, Canada, H3T 1E2

Status
Completed
 
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Regensburg, Germany, 93053

Status
Completed
 
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Investigative Site

GRENOBLE Cedex 09, France, 38043

Status
Completed
 
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Investigative Site

La Jolla, United States, 92093

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
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Investigative Site

Clydebank, United Kingdom, G81 4DY

Status
Completed
 
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Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
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Investigative Site

MARSEILLE, France, 13005

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SW3 6NP

Status
Terminated
 

Trial Design