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

Bayer

Status and phase: Terminated; Phase 2

Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary

Treatments: Drug: Placebo; Drug: Riociguat (BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01172756

2010-018436-41 (EudraCT Number)

14554

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 2

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 3

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo