Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

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The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

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Detailed Description

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Adverse event data will be covered in Adverse events section.

Conditions

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Hypertension, Pulmonary Ventricular Dysfunction, Left

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Riociguat (Adempas, BAY63-2521)

Participants received a single oral dose of 1 mg riociguat.

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY63-2521)

Intervention Type DRUG

1 mg single oral dose

Placebo

Participants received a single oral dose of 1 mg placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single oral dose

Interventions

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Riociguat (Adempas, BAY63-2521)

1 mg single oral dose

Intervention Type DRUG

Placebo

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy