Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502346
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2007-07-10
Brief Title:
A Trial to Determine the Relative Effect of PM101 IV Versus Placebo on Hemodynamics in Healthy Adult Volunteers
Sponsor:
Prism Pharmaceuticals
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Randomized Double-blind Double-dummy Placebo-controlled Trial to Determine the Relative Effect of PM101 IV Versus Placebo on Hemodynamics in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to compare the effect of PM101 IV administered as an immediate intravenous bolus versus placebo on systolic blood pressure Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None