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)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Heart Failure, Heart Decompensation
In brief
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.
Key facts
- Study ID
- NCT01064037
- Run by
- Bayer
- People needed
- 62
- Starts
- 2010-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2015-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
- Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment
- Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload
You may not qualify if…
- Acute de-novo heart failure
- Acute myocardial infarction and/or myocardial infarction within 30 days
- Valvular heart disease requiring surgical intervention during the course of the study
- Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
- Primary hypertrophic cardiomyopathy
- Acute inflammatory heart disease, eg, acute myocarditis
- Unstable angina requiring angiography
Where it is running
- Study site — Detroit, Michigan, United States
- Study site — Cincinnati, Ohio, United States
- Study site — Cleveland, Ohio, United States
- Study site — Nashville, Tennessee, United States
- Study site — Houston, Texas, United States
- Study site — Calgary, Alberta, Canada
- Study site — Vancouver, British Columbia, Canada
- Study site — Québec, Quebec, Canada
- Study site — Brno, Czechia
- Study site — Pardubice, Czechia
- Study site — Prague, Czechia
- Study site — Prague, Czechia
- Study site — Prague, Czechia
- Study site — Jyväskylä, Jyväskylä, Finland
- Study site — Turku, Turku, Finland
- Study site — Dommartin-lès-Toul, France
- Study site — Paris, France
- Study site — Paris, France
- Study site — Paris, France
- Study site — Poitiers, France
- Study site — Nuremberg, Bavaria, Germany
- Study site — Melsungen, Hesse, Germany
- Study site — Mönchengladbach, North Rhine-Westphalia, Germany
- Study site — Kiel, Schleswig-Holstein, Germany
- Study site — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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