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

Phase 2

Terminated

• Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary
• Interventions: Drug: Riociguat (BAY63-2521); Drug: Placebo

• Registration Number: NCT01172756
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction

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Exclusion Criteria

• Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Riociguat (BAY63-2521)	-
Arm 3	Riociguat (BAY63-2521)	-
Arm 2	Riociguat (BAY63-2521)	-
Arm 4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pulmonary artery mean pressure at rest	Peak change from baseline within 6 hours after a single dose of study drug

Secondary Outcome Measures

Name	Time	Method
Adverse event collection	until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat	Within 24 hours after study drug treatment