Single Dose Escalation Study in Patients With Chronic Heart Failure
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00565565
First received: October 31, 2007
Last updated: May 5, 2013
Last verified: May 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 31, 2007 | ||||
| Last Updated Date | May 5, 2013 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The study is to investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics of single doses of orally administered BAY 60-4552 in a single dose escalation design. [ Time Frame: 72 hours ] | ||||
| Change History | Complete list of historical versions of study NCT00565565 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Single Dose Escalation Study in Patients With Chronic Heart Failure | ||||
| Official Title ICMJE | Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design. | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Heart Failure | ||||
| Intervention ICMJE | Drug: BAY60-4552
Single dose escalation starting with 1 mg |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Drug: BAY60-4552 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 47 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00565565 | ||||
| Other Study ID Numbers ICMJE | 12356, 2007-003216-54 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Head Clinical Pharmacology, Bayer HealthCare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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