Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093249
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2004-10-05
Brief Title:
Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery ESCAPE-1
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery ESCAPE-1
Status:
COMPLETED
Status Verified Date:
2014-08
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:
ESCAPE-1
Brief Summary:
The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension
Detailed Description:
Initiation of study drug infusion will commence with the occurrence of protocol-defined preoperative hypertension SBP 160 mmHg as measured via an indwelling arterial line
The study drug clevidipine or placebo may be administered to treat hypertension until one hour has elapsed or until induction of anesthesia whichever occurs first
The primary endpoint of bailout described as defined per protocol as bailout for lack of efficacy bailout for safety reason or bailout due to treatment failure will be determined during the 30-minute period from study drug initiation
The study drug clevidipine or placebo may be administered to treat hypertension until one hour has elapsed or until induction of anesthesia whichever occurs first
The primary endpoint of bailout described as defined per protocol as bailout for lack of efficacy bailout for safety reason or bailout due to treatment failure will be determined during the 30-minute period from study drug initiation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ESCAPE-1 | OTHER | Sponsor | None |