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| Sponsored by: |
Bayer |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00559650 |
Purpose
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 |
|
Congestive Heart Failure |
Drug: Placebo Drug: BAY 58-2667 |
Phase II |
| MedlinePlus related topics: | Heart Failure |
| 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 2008 |
| Arms | Assigned Interventions |
|
Arm 1: Placebo Comparator
n/a
|
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
n/a
|
Drug: BAY 58-2667
Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options "3" or "4") | (ex US: +1) 1-888-842-2937 |
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Show 69 Study Locations |
| Bayer |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
| Study ID Numbers: | 12480, 2007-003059-36 |
| First Received: | November 15, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00559650 |
| Health Authority: | United States: Food and Drug Administration |
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