NCT01064037

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)

A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Heart Decompensation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2010-02-08
• Last updated: 2015-10-08

Locations

70 sites across 16 countries: United States, Canada, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Poland, South Africa, South Korea, Spain, United Kingdom