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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00559650 |
The purpose of this study is to assess a dose titration scheme, of a new drug (BAY 58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Drug: Placebo Drug: BAY 58-2667 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Placebo Controlled, Randomized, Double-Blind, Multi-Center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure |
Estimated Enrollment: | 210 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Placebo Comparator |
Drug: Placebo
Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
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Arm 2: Experimental |
Drug: BAY 58-2667
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+) 1-888-842-2937 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12480, EudraCT Nr: 2007-003059-36 |
Study First Received: | November 15, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00559650 |
Health Authority: | United States: Food and Drug Administration |
Acute decompensated heart failure Double blind study, BAY 58-2667 Soluble guanylate cyclase activator |
Heart Failure Heart Diseases |
Cardiovascular Diseases |