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A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

NCT01064037 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-10-08

No results posted yet for this study

Summary

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

Conditions

Interventions

DRUG

Cinaciguat (BAY58-2667)

Infusion of 150 µg/h during 48h.

DRUG

Cinaciguat (BAY58-2667)

Infusion of 100 µg/h during 48h

DRUG

Cinaciguat (BAY58-2667)

Infusion of 50 µg/h during 48h

DRUG

Placebo

Infusion during 48h

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
2010-04-30
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Poland
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01064037 on ClinicalTrials.gov