Trial Outcomes & Findings for Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage (NCT NCT00978822)

Last Updated: 2023-03-02

Results Overview

All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min) Study closed October 2012

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

30 minutes

Results posted on

2023-03-02

Participant milestones
Measure	Clevidipine Single arm, all patients were receiving clevidipine
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage

Baseline characteristics by cohort
Measure	Clevidipine Butyrate Injectable Emulsion n=5 Participants Clevidipine butyrate injectable emulsion: Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
SBP	146.4 mmHg STANDARD_DEVIATION 2.48 • n=5 Participants

Timeframe: 30 minutes

Population: 5 pts received clevidipine

All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min) Study closed October 2012

Outcome measures
Measure	Clevidipine n=5 Participants Single arm, all patients were receiving clevidipine
Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion.	14.2 min Standard Deviation 6.4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Albany Medical Center

Phone: 2488739855