Clinical trial • Phase II • Cardiology
levosimendan for Heart failure
Phase II trial of levosimendan for Heart failure. 6 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heart failure
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
Phase II trial across 1 site in Belgium.
- Target Sample Size
- 6
Eligibility
Recruits 6 No vulnerable populations selected (isVulnerablePopulationSelected: false).
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false)
Recruitment
- Planned Sample Size
- 6
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 6
Belgium
- Earliest CTIS Part Ii Submission Date
- 21-05-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 114
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- UZ Brussel
- Department Name
- ICU
- Principal Investigator Name
- Matthias Raes
- Principal Investigator Email
- matthias.raes@uzbrussel.be
- Contact Person Name
- Matthias Raes
- Contact Person Email
- matthias.raes@uzbrussel.be
- Number Of Participants
- 6
Sponsor
Primary sponsor
- Full Name
- UZ Brussel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- inhaled levosimendan
- Active Substance
- levosimendan
- Modality
- Small molecule
- Routes Of Administration
- Inhalation
- Route
- Inhalation
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