Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)
NCT00093925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739
Last updated 2014-05-06
Summary
The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
Conditions
Interventions
- DRUG
-
clevidipine
- DRUG
-
nicardipine
Sponsors & Collaborators
-
The Medicines Company
lead INDUSTRY
Principal Investigators
-
Malcolm Lloyd, MD · The Medicines Company - Medical Director, Clinical Operations
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Primary Completion
- 2006-07-31
- Completion
- 2006-09-30
Countries
- United States
Study Locations
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