Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093262
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2004-10-05
Brief Title:
Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery ESCAPE-2
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery ESCAPE-2
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCAPE-2
Brief Summary:
The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting CABG off-pump coronary artery bypass OPCAB or minimally invasive direct coronary artery bypass MIDCAB surgery andor valve replacementrepair procedures were anticipated to be randomly assigned to one of two treatment groups clevidipine or placebo
Detailed Description:
The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug Secondary objectives included assessments of efficacy through measuring time to target blood pressure BP lowering effect defined as 15 reduction in SBP change in mean arterial pressure MAP and the incidence of bailout by causality Assessments for safety included change in heart rate HR from baseline
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-2 | None | None | None |