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Cleviprex (Clevidipine Butyrate) - Summary



Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine butyrate suitable for intravenous administration. Clevidipine butyrate is a dihydropyridine calcium channel blocker.

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

See all Cleviprex indications & dosage >>


Media Articles Related to Cleviprex (Clevidipine Butyrate)

High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Source: MedicineNet Facial Nerve Problems Specialty [2017.09.19]
Title: High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Category: MedicineNet Quiz
Created: 2/9/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 6:02:11 PM

Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Source: MedicineNet Congenital Heart Disease Specialty [2017.07.26]
Title: Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/26/2017 12:00:00 AM

High Blood Pressure (Hypertension)
Source: MedicineNet Polycystic Ovary Specialty [2017.03.31]
Title: High Blood Pressure (Hypertension)
Category: Symptoms and Signs
Created: 1/15/2014 12:00:00 AM
Last Editorial Review: 3/31/2017 12:00:00 AM

Portal Hypertension
Source: MedicineNet nitroglycerin Specialty [2016.09.06]
Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 9/6/2016 12:00:00 AM

Picture of Hypertension
Source: MedicineNet betaxolol ophthalmic Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

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Published Studies Related to Cleviprex (Clevidipine Butyrate)

Clevidipine for the treatment of severe hypertension in adults. [2010]
pharmacodynamic properties, tolerability, and clinical efficacy of clevidipine... CONCLUSION: In the Phase III trials reviewed, clevidipine was effective in

The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. [2008.10]
BACKGROUND: Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery... CONCLUSIONS: CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.

Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. [2008.07]
BACKGROUND: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients... CONCLUSIONS: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.

Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. [2007.10]
BACKGROUND: Clevidipine is an ultrashort-acting, third-generation IV dihydropyridine calcium channel blocker that exerts rapid and titratable arterial blood pressure reduction, with fast termination of effect due to metabolism by blood and tissue esterases. As an arterial-selective vasodilator, clevidipine reduces peripheral vascular resistance directly, without dilating the venous capacitance bed. In this randomized, double-blind, placebo-controlled multicenter trial we evaluated the efficacy and tolerability of clevidipine in treating preoperative hypertension... CONCLUSIONS: Clevidipine was effective in rapidly decreasing blood pressure preoperatively to targeted blood pressure levels and was well tolerated in patients scheduled for cardiac surgery.

Clevidipine for severe hypertension in patients with renal dysfunction: a VELOCITY trial analysis. [2011.04]
INTRODUCTION: Acute and severe hypertension is common, especially in patients with renal dysfunction (RD). Clevidipine is a rapidly acting (t(1/2) approximately 1 min) intravenous (IV) dihydropyridine calcium-channel blocker metabolized by blood and tissue esterases and may be useful in patients with RD. The purpose of this analysis was to assess the safety and efficacy of clevidipine in patients with RD... CONCLUSIONS: This report is the first demonstrating that clevidipine is safe and effective in RD complicated by severe hypertension. Prolonged infusion maintained blood pressure within a target range and allowed successful transition to oral therapy.

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Clinical Trials Related to Cleviprex (Clevidipine Butyrate)

The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy [Recruiting]
This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).

Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) [Not yet recruiting]
Vasospasm occurs frequently after aneurysmal subarachnoid hemorrhage and can lead to strokes. The investigators will investigate if infusion of a novel drug, clevidipine, will decrease vasospasm during the infusion and post infusion period using transcranial doppler monitoring of patients with subarachnoid hemorrhage and moderate severity vasospasm

Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE) [Completed]
The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage (i. e., bleeding in the brain; stroke).

A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients [Completed]
This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.

Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection [Withdrawn]

2. Purpose of the Study -

1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative periods of aortic aneurysm and dissection management. 2. To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management

3. Background & Significance - Surgical treatments for persons with aortic root/arch

dissection or aneurysm have significantly improved survival. However, critical in management of these patients is precise control of blood pressure (BP). With increasing BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the target systolic blood pressure range for these patients is 100-120 mmHg. Several different classes of vasoactive agents are in current use to acutely manage BP but none possess the optimal profile of an ideal vasodilator. Notable limitations include inadequate potency, slow onset and offset of action, multiple receptor function, safety concerns and, importantly, restricted/ineffective titration, which results in clinically significant hemodynamic and cardiovascular perturbations. Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in critical care settings. Clevidipine's pharmacology lends itself to acute management of BP in a broad critical care setting in both surgical and nonsurgical patients. In the current study, the investigators propose to further characterize the hemodynamic effect of CLV in the pre and post-operative management of BP in patients with aortic aneurysm/dissection. 4. Design & Procedures Eligible patients will be approached to participate in the study by the Intensive Care Unit (ICU) attending and/or by a cardiothoracic surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical management and monitoring will be according to standard practice that includes:


- Oxymetry

- Temperature

- Invasive arterial blood pressure

- Recording of routine laboratory results

- Imaging studies including CT/MRI (A)/ Echocardiography

- Pulmonary artery catheter (postoperative patients)

- Mechanical ventilation (postoperative patients)

- According to established protocol for acute intravenous management of arterial

blood pressure in these patients, an upper and lower threshold of systolic blood pressure will be prescribed by the attending physician (the range being (100 mmHg

- 120 mm Hg SBP).

Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent clinical data and information about efficacy and safety will be recorded. • Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the critical care team)

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Page last updated: 2017-09-19

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