Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT01172756
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04095286 - Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants Phase 1
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT02191137 - Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) Phase 4
Completed NCT01959828 - Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery Phase 3
Withdrawn NCT01202045 - Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients N/A
Completed NCT01121458 - Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed Phase 4
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Terminated NCT00825266 - Insulin Resistance in Pulmonary Arterial Hypertension Phase 4
Terminated NCT00384865 - A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension Phase 2
Active, not recruiting NCT03926572 - Acute Decompensation of Pulmonary Hypertension N/A
Completed NCT02826252 - Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20) N/A
Completed NCT02545465 - A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice N/A
Recruiting NCT04498299 - Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
Recruiting NCT02558582 - Effect of Exercise Training in Patients With Pulmonary Hypertension N/A
Active, not recruiting NCT02562235 - Riociguat in Children With Pulmonary Arterial Hypertension (PAH) Phase 3
Completed NCT02755298 - Chronic Clinical Effect of Acetazolamide Phase 2/Phase 3
Completed NCT02576002 - Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) N/A
Terminated NCT03043976 - Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension N/A
Completed NCT01317134 - Endothelial Function in Patients With Pulmonary Arterial Hypertension N/A

External Links