Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093886
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2004-10-07
Brief Title:
Clevidipine in the Perioperative Treatment of Hypertension ECLIPSE-NTG
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events With Nitroglycerin as Active Comparator ECLIPSE-NTG
Status:
COMPLETED
Status Verified Date:
2014-05
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:
ECLIPSE-NTG
Brief Summary:
The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension Approximately 500-900 patients with perioperative 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 nitroglycerin
Detailed Description:
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension as assessed by comparing the incidences of death stroke MI and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative Day 30 Secondary objectives were to evaluate the efficacy of study drug assessed by the blood pressure BP lowering effect and additional safety variables
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