Trial Condition(s):
Hypertension, Pulmonary, Ventricular Dysfunction, Left
A study to test the effects of Riociguat in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction (DILATE)
Bayer Identifier:
14554
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Krankenhaus der Elisabethinen Linz Linz, Austria, 4010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landeskrankenhaus Salzburg Salzburg, Austria, 5020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LKH Graz West Graz, Austria, 8020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Terminated | Contact Us: E-mail: clinical-trials-c[email protected] Phone: Not Available |
Locations Vseobecna fakultni nemocnice Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50924 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Pulmonary artery mean pressure at restTimeframe: Peak change from baseline within 6 hours after a single dose of study drug
Secondary Outcome
- Adverse event collectionTimeframe: until 30 days after study drug treatment
- Plasma concentrations to obtain pharmacokinetic profile of RiociguatTimeframe: Within 24 hours after study drug treatment
Additional Information
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