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Clevidipine Phase III Studies: Perioperative Hypertension - page 2 / 65

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ESCAPE Protocol

Design: two double-blind, randomized, placebo-controlled trials in cardiac surgery

ESCAPE-1: preoperative patients with SBP ≥ 160 mm Hg

ESCAPE-2: postoperative patients with SBP ≥ 140 mm Hg

Primary endpoint: treatment failure

Premature and permanent discontinuation of study drug

Failure to decrease SBP by >15% from baseline within 30 minutes

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Lack of efficacy

-

Insufficient efficacy

-

Safety

Secondary endpoints

Time to target BP

Change in MAP

Change in HR

Levy JH et al. Anesth Analg. 2007;105:918-925

Singla N et al. Anesth Analg. 2008;107:59-67

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