Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00666328
First received: April 22, 2008
Last updated: August 21, 2014
Last verified: August 2014
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Hemorrhage
Intervention: Drug: clevidipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients considered for inclusion in this study were recruited from June 2008 through April 2010 primarily from hospital emergency departments and Neurology Intensive Care Units, having presented with acute hypertension and intracerebral hemorrhage (ICH). Enrollment targeted a subset of ~10 patients requiring intracranial pressure (ICP) monitoring.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were required to have a systolic blood pressure (SBP) greater than 160 mm Hg both prior to enrollment and immediately prior to study drug initiation. Participants with SBP </=160 mm Hg immediately prior to study drug did not receive clevidipine and were treated per standard of care.

Reporting Groups
  Description
Clevidipine Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.

Participant Flow:   Overall Study
    Clevidipine  
STARTED     35 [1]
Modified Intent To Treat (mITT)     33 [2]
COMPLETED     30 [3]
NOT COMPLETED     5  
Death                 2  
Lost to Follow-up                 2  
No longer met eligibility criteria                 1  
[1] Safety population: participants dosed with study drug (primary population for Safety analyses)
[2] mITT population: participants dosed and in whom all inclusion and no exclusion criteria were met
[3] 30/35 completed the study within the Safety population; 28/33 completed within the mITT population.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clevidipine

mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.

Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.


Baseline Measures
    Clevidipine  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
Mean ± Standard Deviation
  63.9  ± 12.14  
Gender  
[units: participants]
 
Female     7  
Male     26  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     29  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaskan Native     0  
Asian     3  
Black or African American     9  
Native Hawaiian or Pacific Islander     0  
White     21  
Baseline Systolic Blood Pressure (SBP)  
[units: mm Hg]
Mean ± Standard Deviation
  186.5  ± 20.39  
Baseline Diastolic Blood Pressure (DBP)  
[units: mm Hg]
Mean ± Standard Deviation
  85.7  ± 12.89  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine   [ Time Frame: Within 30 minutes of study drug initiation ]

2.  Secondary:   Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine   [ Time Frame: Within 30 minutes of study drug initiation ]

3.  Secondary:   Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion   [ Time Frame: Baseline through 30 minutes post initiation of clevidipine infusion ]

4.  Secondary:   Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion   [ Time Frame: Duration of the study drug infusion (up to 96 hours) ]

5.  Secondary:   Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine   [ Time Frame: From study drug initiation through termination (up to 96 h) ]

6.  Secondary:   Mean Dose of Clevidipine During the Treatment Period   [ Time Frame: Up to 96 hours ]

7.  Secondary:   Median Dose of Clevidipine During the Treatment Period   [ Time Frame: Up to 96 hours ]

8.  Secondary:   Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine   [ Time Frame: Up to 96 hours ]

9.  Secondary:   Percent Change in Heart Rate During 30 of Initiation of Clevidipine   [ Time Frame: From study drug initiation through each specified timepoint ]

10.  Secondary:   The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion   [ Time Frame: Within 30 minutes of the initiation of study drug infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jason Campagna. MD, PhD
Organization: The Medicines Company
phone: 973-290-6199
e-mail: jason.campagna@themedco.com


No publications provided


Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00666328     History of Changes
Other Study ID Numbers: TMC-CLV-07-02
Study First Received: April 22, 2008
Results First Received: July 25, 2012
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission