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

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ClinicalTrials.gov Identifier: NCT01172756
Recruitment Status : Terminated (Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.)
First Posted : July 30, 2010
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Ventricular Dysfunction, Left Drug: Riociguat (BAY63-2521) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Pulmonary artery mean pressure at rest [ Time Frame: Peak change from baseline within 6 hours after a single dose of study drug ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: until 30 days after study drug treatment ]
  2. Plasma concentrations to obtain pharmacokinetic profile of Riociguat [ Time Frame: Within 24 hours after study drug treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172756

Linz, Oberösterreich, Austria, 4010
Graz, Steiermark, Austria, 8020
Graz, Steiermark, Austria, 8036
Salzburg, Austria, 5020
Wien, Austria, 1090
Czech Republic
Praha 2, Czech Republic, 12808
Köln, Nordrhein-Westfalen, Germany, 50924
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01172756     History of Changes
Other Study ID Numbers: 14554
2010-018436-41 ( EudraCT Number )
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Bayer:
Pulmonary Hypertension
Left ventricular dysfunction

Additional relevant MeSH terms:
Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases