VELOCITY Trial Published in Annals of Emergency Medicine
The Medicines Company (NASDAQ: MDCO) today announced that the
results of VELOCITY, a pivotal Phase 3 safety and efficacy trial of its
new intravenous (IV) therapy Cleviprex™
(clevidipine butyrate) injectable emulsion, were published in the August
issue of the Annals of Emergency Medicine. The clinical trial
demonstrated that Cleviprex is safe and effective for the treatment of
acute, severe hypertension. Cleviprex was approved this month by the
U.S. Food and Drug Administration (FDA) for the reduction of blood
pressure when the use of oral therapy is not feasible or not desirable.
VELOCITY, a prospective, multicenter, open-label, single-arm study,
evaluated the safety and efficacy of Cleviprex in 126 patients in the
emergency room or intensive care unit who had acute, severe hypertension
(defined as systolic blood pressure greater than 180 mm Hg and/or
diastolic blood pressure greater than 115 mm Hg). Cleviprex was
administered using non–weight-based dosing,
and infusions were adjusted to rapidly bring blood pressure to a
physician-specified target range using blood pressure cuff monitoring.
The primary efficacy endpoint was the percentage of patients in whom
systolic blood pressure was successfully reduced to the target range
within 30 minutes of initiating therapy.
“The VELOCITY study demonstrates the ability
of Cleviprex to control blood pressure rapidly and predictably in
patients with acute, severe hypertension,”
said lead investigator Charles Pollack, MD, University of Pennsylvania,
Department of Emergency Medicine. “With the
recent approval of Cleviprex, physicians will have a valuable therapy to
help effectively manage and maintain these patients in the critical care
setting.”
In VELOCITY:
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Study patients commonly presented with both acute hypertension and
end-organ injury; 81% had demonstrable end-organ injury at baseline.
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Within 30 minutes of starting clevidipine, 88.9% of treated patients
were brought within the target range.
