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

Bayer

Status and phase

Completed

Phase 3

Conditions

Pulmonary Hypertension

Treatments

Drug: Placebo

Drug: Riociguat (Adempas, BAY63-2521)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00810693

2008-003482-68 (EudraCT Number)

12934

Details and patient eligibility

About

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).

Enrollment

445 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.).

Exclusion criteria

All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

445 participants in 3 patient groups, including a placebo group

Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT

Experimental group

Description:

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

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT

Experimental group

Description:

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

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo