Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG) (ECLIPSE-NTG)
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|ClinicalTrials.gov Identifier: NCT00093886|
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : May 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: clevidipine Drug: nitroglycerin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||629 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||April 2005|
Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours.
Other Name: clevidipine, Cleviprex
Active Comparator: nitroglycerin
Nitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.
- Incidence of death, stroke, MI and renal dysfunction [ Time Frame: Initiation of study drug infusion through post-operative Day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093886
|Study Director:||Malcolm Lloyd, MD||The Medicines Company - Medical Director, Clinical Operations|