CLEVIPREX® (clevidipine) provided blood pressure reduction
in a range of patients and various clinical settings
CLEVIPREX efficacy was evaluated across 4 clinical studies1-5
Responsive BP reduction within minutes in the preoperative clinical setting1,2
92.5% of patients on CLEVIPREX achieved treatment success*2
The primary endpoint was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline or the discontinuation of study treatment for any reason within the 30-minute period after study drug initiation.2

*Treatment success was defined as a reduction of SBP of ≥15% from baseline within the 30-minute period from study drug initiation.

Target SBP reduction (≥15% from baseline) achieved with a median time of 6 minutes2
Study type | Randomized, double-blind, placebo-controlled, phase 3 study |
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Purpose | To determine the safety and efficacy of CLEVIPREX in treating preoperative hypertension |
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Patient population |
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Key inclusion criteria | SBP ≥160 mmHg and clinically assessed as needing ≥15% reduction in SBP |
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Protocol |
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Responsive BP reduction within minutes in the postoperative clinical setting1,3
91.8% of patients on CLEVIPREX achieved treatment success*3
The primary endpoint was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline or the discontinuation of study treatment for any reason within the 30-minute period after study drug initiation.3

*Treatment success was defined as a reduction of SBP of ≥15% from baseline within the 30-minute period from study drug initiation.

†The decrease in placebo group SBP reflects the number of placebo patients (N=49 at baseline) who bailed out during the 30-minute infusion period (N=10 remaining at 30 minutes).
Target SBP reduction (≥15% from baseline) achieved with a median time of 5.3 minutes3
Study type | Randomized, double-blind, placebo-controlled, phase 3 study |
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Purpose | To determine the safety and efficacy of CLEVIPREX in treating postoperative hypertension |
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Patient population |
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Key inclusion criteria | SBP ≥140 mmHg and clinically assessed as needing ≥15% reduction in SBP |
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Protocol |
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Control of acute severe hypertension with low rate of overshoot4

Mean percent change in SBP with clevidipine (mITT population, n=117).
- Nearly 89% of acute severe hypertension patients achieved target BP range4
- Target SBP range achieved with a median time of 10.9 minutes4
- No change in lipid profile was observed*4
- Mean duration of infusion=21 hours1,4
*Increased blood triglycerides have been observed in the postmarketing experience of CLEVIPREX.
VELOCITY safety data
- Serious adverse events from CLEVIPREX initiation to 7 days later were reported in 11 of 126 (8.7%) safety population patients4
- Headache was the most frequently reported adverse event, with an overall incidence of 6.3% (8/126), followed by nausea 4.8% (6/126), chest discomfort 3.2% (4/126), and vomiting 3.2% (4/126)4
- The incidence of adverse events leading to study drug discontinuation for CLEVIPREX in severe hypertension was 4.8%1
Low rate of overshoot† in acute severe hypertension patients4
- 1.6% of patients (N=2) experienced overshoot within the first 3 minutes after start of infusion. These 2 patients continued CLEVIPREX infusion beyond 18 hours without experiencing any adverse events4
- In this study, the incidence of adverse events leading to study drug discontinuation was 4.8%1
†Overshoot was defined as SBP below the prespecified initial target range within the first 3 minutes of starting the infusion.
VELOCITY study design4
An open-label, single-arm clinical trial in 126 patients with severe hypertension (SBP >180 mmHg or DBP >115 mmHg). CLEVIPREX infusion was initiated at 2 mg/hr and up-titrated every 3 minutes, doubling up to a maximum dose of 32 mg/hr as required to achieve a prespecified target blood pressure range within 30 minutes (primary endpoint). The SBP target range was prespecified, patient specific, and calculated as 20–40 mmHg range from upper to lower limit. It was selected by the treating physician’s discretion and according to the patient’s presenting condition, baseline blood pressure, and presence of comorbidities.
SBP changes over time with CLEVIPREX5
Median time to achieve target SBP range was
5.5 minutes5
- All patients achieved target SBP within 30 minutes5
- 96.9% achieved target SBP with CLEVIPREX monotherapy5
- Mild/moderate hypotension was reported in 3 patients and resolved with dose reduction or drug discontinuation5

Mean (+/-SE) change in SBP with clevidipine (mITT population, n=33).
Mean baseline SBP=186 mmHg.
CLEVIPREX is not indicated for the prevention or treatment of stroke.
Study type | Multi-center, prospective, open-label, pilot, phase 3b study |
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Purpose | Evaluate the efficacy and safety of CLEVIPREX in managing hypertension (SBP >160 mmHg) in patients presenting within 6 or 12 hours of symptom onset with intracerebral hemorrhage (ICH) |
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Patient population | N=35 |
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Key inclusion criteria |
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Protocol6 |
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Dr. Horowitz speaks about CLEVIPREX
Renowned anesthesiologist Dr. Todd Horowitz discusses CLEVIPREX clinical trial results and dosing in a series of informative videos for healthcare professionals.
CLEVIPREX Flashcard
Download a PDF overview of helpful information about CLEVIPREX.
Individualized, titratable administration1
CLEVIPREX offers low-volume, non–weight-based dosing that is independent of renal or hepatic function.
Recommended in Stroke Guidelines
CLEVIPREX has been recommended in the AHA/ASA Acute Ischemic Stroke Guidelines since 2018.7
