Hypertension, Pulmonary Clinical Trial
— DILATEOfficial 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
Verified date | November 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Office for Safety in Health Care |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 39 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Austria, Czech Republic, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary artery mean pressure at rest | Peak change from baseline within 6 hours after a single dose of study drug | No | |
Secondary | Adverse event collection | until 30 days after study drug treatment | Yes | |
Secondary | Plasma concentrations to obtain pharmacokinetic profile of Riociguat | Within 24 hours after study drug treatment | No |
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