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Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

NCT00559650 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-04-18

No results posted yet for this study

Summary

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) 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.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Placebo

Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

DRUG

Cinaciguat (BAY58-2667)

Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • United States
  • Canada
  • Croatia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Poland
  • Russia
  • Serbia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559650 on ClinicalTrials.gov