Open-label, international, multicenter, non-placebo controlled (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)

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) - RESPITE

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001759-10-DE

Enrollment

Registered

2013-10-15

Start date

2014-01-03

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Interventions

Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female patients (18 -75 years of age) with idiopathic, heritable, drug/toxin induced PAH or associated PAH due to congenital heart disease (i.e. atrial septal defects if corrected for more than 12 months) 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 of 165-440 m • Cardiac index =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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 in the judgment of the investigator (e.g. based on a clean CT lung scan) • 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 woman (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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether it is safe, feasible and beneficial to replace PDE-5i therapy with Riociguat in PAH patients demonstrating insufficient response to PDE-5 inhibition.;Secondary Objective: Not applicable;Primary end point(s): There is no primary endpoint in this study. All efficacy variables are exploratory. ;Timepoint(s) of evaluation of this end point: Not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): • Change from baseline in 6 minute walking distance. • Change in cardiac index. • Change in N-terminal pro-brain natriuretic peptide. • Change in World Health Organization functional class. • Proportion of patients with clinical worsening. • Change in quality of life EuroQol questionnaire. • Change in quality of life Living with pulmonary hypertension questionnaire. • Proprtion of patients without clinical worsening who achieve at least World Health Organization functional class II and an improvement in 6 minute walking distance of greater than or equal to 30 metres. ;Timepoint(s) of evaluation of this end point: After 12 and 24 weeks (except for change in cardiac index: after 24 weeks only)	—

Measure

Time frame

Secondary end point(s): • Change from baseline in 6 minute walking distance. • Change in cardiac index. • Change in N-terminal pro-brain natriuretic peptide. • Change in World Health Organization functional class. • Proportion of patients with clinical worsening. • Change in quality of life EuroQol questionnaire. • Change in quality of life Living with pulmonary hypertension questionnaire. • Proprtion of patients without clinical worsening who achieve at least World Health Organization functional class II and an improvement in 6 minute walking distance of greater than or equal to 30 metres. ;Timepoint(s) of evaluation of this end point: After 12 and 24 weeks (except for change in cardiac index: after 24 weeks only)

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Countries

Belgium, Canada, Czech Republic, Germany, Switzerland, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trialscontact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026