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

November 3, 2014 updated by: Bayer

Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1090
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
    • Steiermark
      • Graz, Steiermark, Austria, 8036
      • Graz, Steiermark, Austria, 8020
  • Czech Republic
      • Praha 2, Czech Republic, 12808
  • Germany
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Riociguat (BAY63-2521)
0.5 mg single oral dose
Drug: Riociguat (BAY63-2521)
1 mg single oral dose
Drug: Riociguat (BAY63-2521)
2 mg single oral dose
Experimental: Arm 2
Drug: Riociguat (BAY63-2521)
0.5 mg single oral dose
Drug: Riociguat (BAY63-2521)
1 mg single oral dose
Drug: Riociguat (BAY63-2521)
2 mg single oral dose
Experimental: Arm 3
Drug: Riociguat (BAY63-2521)
0.5 mg single oral dose
Drug: Riociguat (BAY63-2521)
1 mg single oral dose
Drug: Riociguat (BAY63-2521)
2 mg single oral dose
Placebo Comparator: Arm 4
Drug: Placebo
single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary artery mean pressure at rest
Time Frame: Peak change from baseline within 6 hours after a single dose of study drug
Peak change from baseline within 6 hours after a single dose of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event collection
Time Frame: until 30 days after study drug treatment
until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Time Frame: Within 24 hours after study drug treatment
Within 24 hours after study drug treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

July 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14554
  • 2010-018436-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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