A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
(PATENT-1 Trial)

Recruiting in Palo Alto (17 mi)

+158 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Eligibility Criteria

Inclusion Criteria

Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)

Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDTExperimental Treatment1 Intervention

Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks

Group II: Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDTExperimental Treatment1 Intervention

Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks

Group III: PlaceboPlacebo Group1 Intervention

Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks