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Last Updated: April 23, 2025

CLINICAL TRIALS PROFILE FOR CLEVIPREX


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All Clinical Trials for Cleviprex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00666328 ↗ Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE) Completed The Medicines Company Phase 3 2008-06-01 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).
NCT00799604 ↗ Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT) Completed The Medicines Company Phase 2 2008-11-01 This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.
NCT00803634 ↗ Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO) Completed The Medicines Company Phase 3 2008-12-01 The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cleviprex

Condition Name

Condition Name for Cleviprex
Intervention Trials
Hypertension 9
Subarachnoid Hemorrhage 3
Hemorrhage 1
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Condition MeSH

Condition MeSH for Cleviprex
Intervention Trials
Hypertension 8
Hemorrhage 5
Subarachnoid Hemorrhage 3
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Clinical Trial Locations for Cleviprex

Trials by Country

Trials by Country for Cleviprex
Location Trials
United States 36
Germany 3
France 1
Switzerland 1
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Trials by US State

Trials by US State for Cleviprex
Location Trials
Ohio 4
North Carolina 4
New York 4
California 3
Michigan 3
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Clinical Trial Progress for Cleviprex

Clinical Trial Phase

Clinical Trial Phase for Cleviprex
Clinical Trial Phase Trials
Phase 4 6
Phase 3 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Cleviprex
Clinical Trial Phase Trials
Withdrawn 5
Completed 4
Unknown status 2
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Clinical Trial Sponsors for Cleviprex

Sponsor Name

Sponsor Name for Cleviprex
Sponsor Trials
The Medicines Company 10
Henry Ford Health System 2
Methodist Healthcare 1
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Sponsor Type

Sponsor Type for Cleviprex
Sponsor Trials
Industry 12
Other 10
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CLEVIPREX: Clinical Trials, Market Analysis, and Projections

Introduction to CLEVIPREX

CLEVIPREX, also known as clevidipine, is a late-generation dihydropyridine calcium channel antagonist used for the management of acute hypertension in various clinical settings, particularly in the perioperative period. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Safety Profile

ESCAPE-1 and ESCAPE-2 Studies

The efficacy and safety of CLEVIPREX were extensively evaluated in two Phase III double-blind, randomized, parallel, placebo-controlled, multicenter trials: ESCAPE-1 and ESCAPE-2. These studies involved cardiac surgery patients, focusing on preoperative and postoperative use, respectively. The primary endpoint was the incidence of treatment failure, defined as the inability to decrease systolic blood pressure (SBP) by ≥15% from baseline or the discontinuation of study treatment within 30 minutes after initiation[1][3].

Common Adverse Events

In these trials, common adverse events (AEs) reported by ≥5.7% of CLEVIPREX-treated patients in the preoperative setting (ESCAPE-1) and ≥10% in the postoperative setting (ESCAPE-2) included events such as headache, nausea, and hypotension. The AE profile was generally similar to that of the placebo group and other comparator agents[1].

ECLIPSE Studies

The ECLIPSE trials, a series of three parallel, prospective, randomized, open-label studies, compared CLEVIPREX with other blood pressure-lowering agents like nitroglycerin, sodium nitroprusside, and nicardipine in patients undergoing cardiac surgery. These studies found that the incidence of serious AEs was similar between CLEVIPREX and the comparator agents, with no AEs being more than 2% more common with CLEVIPREX than with the average of all comparators[1].

Ongoing and Future Studies

The CLEVER Study, a prospective, 2-arm, randomized, single-center pilot study, is currently assessing the safety and efficacy of intensive blood pressure control using CLEVIPREX in acute ischemic stroke (AIS) patients undergoing mechanical thrombectomy. This study aims to evaluate the outcomes of patients with systolic blood pressure goals of either 90-120mmHg or 90-160mmHg[4].

Market Analysis

Market Size and Growth

The global CLEVIPREX market is projected to grow significantly, driven by increasing demand for effective hypertension treatments. As of 2024, the market size was valued at USD 356.74 million and is expected to reach USD 496.71 million by 2031, growing at a compound annual growth rate (CAGR) of 4.66% during the forecast period[2].

Market Segmentation

The market is segmented based on type, application, and geography. The purity >98% segment is expected to grow considerably, indicating a high demand for high-quality medicines. The pharmaceutical intermediates application segment dominated the market in 2021 and is expected to continue its growth due to increasing development by key players and rising government initiatives in the pharmaceutical industry[2].

Geographic Distribution

North America, particularly the U.S. and Canada, dominates the CLEVIPREX market due to the presence of several key market players and advanced pharmaceutical infrastructure. Other regions, including Europe, Asia Pacific, Latin America, and the Middle East and Africa, are also expected to contribute to the market growth[2].

Market Drivers and Trends

Increasing Incidence of Hypertension

The global prevalence of hypertension, estimated to affect around 1 billion people worldwide, is a significant driver for the CLEVIPREX market. As hypertension rates continue to rise, especially in developing countries, the demand for effective and fast-acting treatments like CLEVIPREX is expected to increase[2].

Advantages Over Other Medications

CLEVIPREX offers several advantages, including a rapid onset of action and a short duration of action, which reduces the risk of adverse effects. These properties make it a valuable treatment option for severe hypertension in hospitalized patients[2].

Favorable Reimbursement Policies

Favorable reimbursement policies also contribute to the growing market adoption of CLEVIPREX. These policies support the use of this medication in clinical settings, making it more accessible to patients who need rapid blood pressure control[2].

Future Projections

Market Growth

The CLEVIPREX market is expected to continue its growth trajectory, driven by the increasing demand for high-quality pharmaceutical intermediates and the expanding prevalence of hypertension globally. The market is projected to reach USD 496.71 million by 2031, with a CAGR of 4.66% during the forecast period[2].

Technological and Regulatory Trends

Future market growth will also be influenced by technological advancements and regulatory changes. As new clinical trials and studies emerge, they may further solidify the position of CLEVIPREX in the market or open up new application areas, such as its use in acute ischemic stroke patients[4].

Key Takeaways

  • Clinical Trials: CLEVIPREX has demonstrated safety and efficacy in multiple clinical trials, including the ESCAPE-1, ESCAPE-2, and ECLIPSE studies.
  • Market Growth: The global CLEVIPREX market is projected to grow from USD 356.74 million in 2024 to USD 496.71 million by 2031, with a CAGR of 4.66%.
  • Market Drivers: Increasing incidence of hypertension, advantages over other medications, and favorable reimbursement policies are key drivers.
  • Future Projections: The market is expected to continue growing, driven by technological advancements and expanding application areas.

FAQs

What is CLEVIPREX used for?

CLEVIPREX is used for the management of acute elevation of blood pressure in perioperative settings, particularly in patients undergoing cardiac surgery.

What are the common adverse events associated with CLEVIPREX?

Common adverse events include headache, nausea, and hypotension, similar to those observed with comparator agents and placebo.

How does the CLEVIPREX market segment?

The market is segmented based on type (purity >98% and <98%), application (pharmaceutical intermediates, chemical intermediates, and others), and geography (North America, Europe, Asia Pacific, etc.).

What drives the growth of the CLEVIPREX market?

The growth is driven by the increasing incidence of hypertension, advantages of CLEVIPREX over other medications, and favorable reimbursement policies.

Are there ongoing clinical trials for CLEVIPREX?

Yes, the CLEVER Study is an ongoing prospective, 2-arm, randomized, single-center pilot study assessing the safety and efficacy of CLEVIPREX in acute ischemic stroke patients.

Sources

  1. CLEVIPREX Safety of Clevidipine in Clinical Trials - Cleviprex.com
  2. Cleviprex Market Size, Share, Scope, Trends, Analysis & Forecast - Verified Market Research
  3. Summary Basis of Decision for Cleviprex - Health Products and Food Branch
  4. Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke - CenterWatch
  5. Cleviprex Market Report 2024 (Global Edition) - Cognitive Market Research

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