• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Cleviprex (clevidipine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Cleviprex (clevidipine)

  • Profile

Profile

Contact Information

Contact: Chiesi
Website: https://cleviprex.com/

Currently Enrolling Trials

    Show More

    General Information

    Cleviprex is an intravenous short acting dihydropyridine calcium channel antagonist. Clevidipine acts by selectively relaxing smooth muscle cells that line small arteries. This results in widening of the arterial lumen and reduction of blood pressure since the small arterioles are the primary resistance vessel within the vasculature.

    Cleviprex is specifically indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

    Cleviprex is supplied as a sterile liquid emulsion designed for intravenous administration. The recommended initial dose of the drug is 1-2 mg/hour until the desired blood pressure reduction is achieved.

    Dose titration: The dose may be doubled at short (90 second) intervals initially. As the blood pressure approaches goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5-10 minutes.

    Maintenance dose: The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour.

    Maximum dose: Most patients were treated with maximum doses of 16 mg/hour or less. Because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Cleviprex infusion is recommended per 24-hour period.

    Mechanism of Action

    Cleviprex is an intravenous short acting dihydropyridine calcium channel antagonist. Clevidipine acts by selectively relaxing smooth muscle cells that line small arteries. This results in widening of the arterial lumen and reduction of blood pressure since the small arterioles are the primary resistance vessel within the vasculature. Clevidipine butyrate does not reduce cardiac filling pressure (pre-load), confirming lack of effects on the venous capacitance vessels.

    Side Effects

    Adverse events associated with the use of Cleviprex in the perioperative setting may include, but are not limited to, the following:

    • Acute renal failure
    • Atrial fibrillation
    • Nausea

    Adverse events associated with the use of Cleviprex for patients with severe hypertension may include, but are not limited to, the following:

    • Headache
    • Nausea
    • Vomiting

    Adverse events associated with the use of Cleviprex for patients with severe or essential hypertension may include, but are not limited to, the following:

    • Myocardial infarction
    • Cardiac arrest
    • Syncope
    • Dyspnea

    Clinical Trial Results

    The FDA approval of Cliviprex for perioperative hypertension was based on the results of two clinical trials. These double-blind, randomized, parallel, placebo controlled, multicenter trials enrolled cardiac surgery patients undergoing coronary artery bypass grafting, with or without valve replacement.

    ESCAPE-1
    This study evaluated the pre-operative use of Cleviprex. Inclusion required a systolic pressure >160 mmHg and the mean baseline blood pressure was 178/77 mmHg. Cleviprex was infused preoperatively for 30 minutes, until treatment failure, or until induction of anesthesia, whichever came first. The maximum infusion time was 60 minutes. Cleviprex was started at a dose of 1-2 mg/hour and was titrated upwards, as tolerated, in doubling increments every 90 seconds up to an infusion rate of 16 mg/hour in order to achieve the desired blood pressure-lowering effect. At doses above 16 mg/hour increments were 7 mg/hour. The average Cleviprex infusion rate in ESCAPE-1 was 15.3 mg/hour. The subjects treated with clevidipine achieved treatment success (at least a 15% reduction in blood pressure) 92.5% of the time, compared to 17.3% in the placebo arm. Cleviprex lowered blood pressure within 2-4 minutes.

    ESCAPE-2
    This study evlauated the post-operative use of Cleviprex. Inclusion required a systolic pressure of >140 mmHg within 4 hours of the completed surgery. The mean baseline blood pressure was 150/71 mmHg. Cleviprex was infused postoperatively for a minimum of 30 minutes unless alternative therapy was required. Infusion of Cleviprex was started at a dose of 1-2 mg/hour and was titrated upwards, as tolerated, in doubling increments every 90 seconds up to an infusion rate of 16 mg/hour in order to achieve the desired blood pressure-lowering effect. At doses above 16 mg/hour increments were 7 mg/hour. The average Cleviprex infusion rate was 5.1 mg/hour. Treatment success was achieved in 91.8% of clevidipine-treated patients compared with 20.4% of placebo-treated patients. Median time to achieving target SBP was 5.3 min with cleviprex.

    ECLIPSE Studies
    These three phase III open label studies enrolled 1,512 subjects who were randomized to receive Cleviprex, nitroglycerin (perioperative hypertension), sodium nitroprusside (perioperative hypertension), or nicardipine (postoperative hypertension), for the treatment of hypertension in cardiac surgery. The mean exposure was 8 hours at 4.5 mg/hour for the 752 patients who were treated with Cleviprex. Blood pressure control was assessed by measuring the magnitude and duration of SBP excursions outside the predefined pre- and post-operative SBP target range of 75-145 mmHg and the predefined intra-operative SBP range of 65-135 mmHg. In general, blood pressure control was similar with the four treatments.

    Severe Hypertension
    Cleviprex was evaluated in an open-label, uncontrolled clinical trial dubbed VELOCITY in 126 patients with severe hypertension. Cleviprex infusion was initiated at 2 mg/hour and up-titrated every 3 minutes, doubling up to a maximum dose of 32 mg/hour as required to achieve a prespecified target blood pressure range within 30 minutes (primary endpoint). The transition to oral antihypertensive therapy was assessed for up to 6 hours following cessation of Cleviprex infusion. The average infusion rate was 9.5 mg/hour. The mean duration of Cleviprex exposure was 21 hours. Transition to oral antihypertensive therapy within 6 hours after discontinuing Cleviprex infusion was successful in 91% of patients. Infusion of clevidipine reduced systolic blood pressure by 6% (12 mmHg) within 3 minutes, by 15% after 9.5 minutes and by 27% (55 mmHg) at 18 hours. Target blood pressure was reached in a median time of 10.9 minutes and 89% of patients achieved their target within 30 minutes.

    Approval Date: 2008-08-01
    Company Name: Chiesi
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing