Study 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.
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
DILATE
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
2 other identifiers
interventional
39
3 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 4, 2014
November 1, 2014
2.3 years
July 19, 2010
November 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary artery mean pressure at rest
Peak change from baseline within 6 hours after a single dose of study drug
Secondary Outcomes (2)
Adverse event collection
until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Within 24 hours after study drug treatment
Study Arms (4)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction
You may not qualify if:
- Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (7)
Unknown Facility
Graz, Styria, 8020, Austria
Unknown Facility
Graz, Styria, 8036, Austria
Unknown Facility
Linz, Upper Austria, 4010, Austria
Unknown Facility
Vienna, Vienna, 1090, Austria
Unknown Facility
Salzburg, 5020, Austria
Unknown Facility
Prague, 12808, Czechia
Unknown Facility
Cologne, North Rhine-Westphalia, 50924, Germany
Related Publications (1)
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.
PMID: 24991733DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 30, 2010
Study Start
July 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 4, 2014
Record last verified: 2014-11