NCT00093249

Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	clevidipine	Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
DRUG	placebo	Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2004-10-07
• Last updated: 2014-08-22

Locations

12 sites across 1 country: United States