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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01172756
First received: July 19, 2010
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Hypertension, Pulmonary
Ventricular Dysfunction, Left
 Drug: Riociguat (BAY63-2521)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pulmonary artery mean pressure at rest [ Time Frame: Peak change from baseline within 6 hours after a single dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: until 30 days after study drug treatment ] [ Designated as safety issue: Yes ]
  • Plasma concentrations to obtain pharmacokinetic profile of Riociguat [ Time Frame: Within 24 hours after study drug treatment ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172756

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01172756     History of Changes
Other Study ID Numbers: 14554, 2010-018436-41
Study First Received: July 19, 2010
Last Updated: November 7, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Bayer:
Pulmonary Hypertension
Left ventricular dysfunction

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

ClinicalTrials.gov processed this record on May 19, 2013