drugset / Trial / NCT00565565
Single Dose Escalation Study in Patients With Chronic Heart Failure
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-12
- Completion
- 2009-04
Publications
- Results Acute hemodynamic response to single oral doses of BAY 60-4552, a soluble guanylate cyclase stimulator, in patients with biventricular heart failure. V Mitrovic, B Swidnicki, A Ghofrani, W Mück, N Kirschbaum, J Mittendorf, J-P Stasch, G Wensing, R Frey, S Lentini. BMC Pharmacology 2009; 9(Suppl 1): P51.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAY60-4552 | Unknown | 1 mg | Oral |
| Subject | BAY60-4552 | Unknown | 2.5 mg | Oral |
| Subject | BAY60-4552 | Unknown | 5 mg | Oral |
| Subject | BAY60-4552 | Unknown | 7.5 mg | Oral |
| Subject | BAY60-4552 | Unknown | 10 mg | Oral |