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A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (LEPHT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01065454
First received: February 8, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction


Condition Intervention Phase
Hypertension, Pulmonary
Ventricular Dysfunction, Left
 Drug: Riociguat (BAY63-2521)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63 2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pulmonary artery mean pressure at rest [ Time Frame: Change from baseline after 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: Until week 16 + 4 weeks Follow-up ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile of Riociguat [ Time Frame: Until week 16 ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: April 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Experimental: Arm 2 Drug: Riociguat (BAY63-2521)
up to 1 mg three times a day (increasing from 0.5 to 1 mg)
Experimental: Arm 3 Drug: Riociguat (BAY63-2521)
fixed 0.5 mg three times a day
Placebo Comparator: Arm 4 Drug: Placebo
Placebo three times a day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy

Exclusion Criteria:

  • Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065454

  Show 111 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01065454     History of Changes
Other Study ID Numbers: 14308, 2009-015878-35
Study First Received: February 8, 2010
Last Updated: April 8, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Denmark: Danish Medicines Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Singapore: Health Sciences Authority
United States: Food and Drug Administration

Keywords provided by Bayer:
Pulmonary Hypertension
Left ventricular dysfunction

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Ventricular Dysfunction, Left
Ventricular Dysfunction
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases

ClinicalTrials.gov processed this record on June 18, 2013