NCT01067859

A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients 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 Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (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

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Cinaciguat (BAY58-2667)	Infusion of 25 µg/h during 48 hours
DRUG	Cinaciguat (BAY58-2667)	Infusion of 10 µg/h during 48 hours
DRUG	Placebo	Infusion of placebo during 48 hours

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2010-02-12
• Last updated: 2015-10-08

Locations

30 sites across 9 countries: United States, Argentina, Austria, Belgium, France, Germany, Ireland, Mexico, Philippines