Clinical trial • Phase II • Cardiology
Rosuvastatin for Healthy volunteers
Phase II trial of Rosuvastatin for Healthy volunteers. 12 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-06-2024
- First CTIS Authorization Date
- 21-08-2024
Trial design
Phase II trial across 1 site in Netherlands.
- Target Sample Size
- 12
Eligibility
Recruits 12 isVulnerablePopulationSelected: false; no additional vulnerable population, consent or assent handling details provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected: false; no additional vulnerable population, consent or assent handling details provided in the record.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-08-2024
- Latest Decision Or Authorization Date
- 19-02-2025
- Processing Time Days
- 186
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal Medicine
- Principal Investigator Name
- Melvin Lafeber
- Principal Investigator Email
- m.lafeber@erasmusmc.nl
- Contact Person Name
- Melvin Lafeber
- Contact Person Email
- m.lafeber@erasmusmc.nl
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Rosuvastatin 10 mg
- Active Substance
- Rosuvastatin
- Modality
- Small molecule
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
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