A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

Phase 2TerminatedNCT01172756

Bayer39 enrolled

Overview

The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension, Pulmonary Ventricular Dysfunction, Left

Interventions

Riociguat (BAY63-2521)DRUG

0.5 mg single oral dose

Riociguat (BAY63-2521)DRUG

1 mg single oral dose

Riociguat (BAY63-2521)DRUG

2 mg single oral dose

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction Exclusion Criteria: * Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

Locations (7)

Unnamed facility

Vienna, State of Vienna, Austria

Unnamed facility

Graz, Styria, Austria

Unnamed facility

Graz, Styria, Austria

Unnamed facility

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

Pulmonary artery mean pressure at rest

Time frame: Peak change from baseline within 6 hours after a single dose of study drug

Secondary Outcomes

Adverse event collection

Time frame: until 30 days after study drug treatment

Plasma concentrations to obtain pharmacokinetic profile of Riociguat

Time frame: Within 24 hours after study drug treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.