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NCT01172756 Clinical Trial

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

Hypertension, Pulmonary Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01172756
Other study ID # 14554
Secondary ID 2010-018436-41
Status Terminated
Phase Phase 2
First received July 19, 2010
Last updated November 3, 2014
Start date July 2010
Est. completion date October 2012

Study information
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

Clinical Trial 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

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Riociguat (BAY63-2521)
0.5 mg single oral dose
• Riociguat (BAY63-2521)
1 mg single oral dose
• Riociguat (BAY63-2521)
2 mg single oral dose
• Placebo
single oral dose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany, 

Outcome
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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