Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02007629
• Date of registration: 06/12/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor RESPITE
• Scientific title: 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)
• Date of first enrolment: February 18, 2014
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02007629
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, France, Germany, Italy, Switzerland, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Riociguat (Adempas, BAY63-2521)

Primary Outcome(s)

Change from baseline in 6 Minute Walking Distance (6MWD) [Time Frame: Baseline, Week 12 and Week 24]

Secondary ID(s)

2013-001759-10

16719

Source(s) of Monetary Support

Please refer to primary and secondary sponsors