Back to resultsA Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction (DILATE)
Primary Purpose
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Riociguat (BAY63-2521)
Riociguat (BAY63-2521)
Riociguat (BAY63-2521)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Pulmonary Hypertension, Left ventricular dysfunction
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Pulmonary artery mean pressure at rest
Secondary Outcome Measures
Adverse event collection
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01172756
Brief Title
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
Acronym
DILATE
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 Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Keywords
Pulmonary Hypertension, Left ventricular dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Riociguat (BAY63-2521)
Intervention Description
0.5 mg single oral dose
Intervention Type
Drug
Intervention Name(s)
Riociguat (BAY63-2521)
Intervention Description
1 mg single oral dose
Intervention Type
Drug
Intervention Name(s)
Riociguat (BAY63-2521)
Intervention Description
2 mg single oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single oral dose
Primary Outcome Measure Information:
Title
Pulmonary artery mean pressure at rest
Time Frame
Peak change from baseline within 6 hours after a single dose of study drug
Secondary Outcome Measure Information:
Title
Adverse event collection
Time Frame
until 30 days after study drug treatment
Title
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Time Frame
Within 24 hours after study drug treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8020
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24991733
Citation
Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Learn more about this trial
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
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