HypertensionPhase 4NCT01910532
The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
A Phase 4 study testing Clevidipine in people with Hypertension, run by Mario Ammirati at 1 site in United States.
Trial summary
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Clevidipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years or older
- Written informed consent from the patient or their legal representative family member before initiation of any study-related procedures
- Patients who clinically require Intracranial Pressure Monitoring device
- Patients who have baseline systolic blood pressure (SBP) (immediately prior to initiation of Clevidipine) > 160 mmHg measured using an arterial line
- Patients who required IV antihypertensive therapy to achieve SBP ≤ 160 mm Hg
Who cannot join
- Patients who are prisoners
- Patients who received an oral antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who received any other IV antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who have fixed dilated pupils and/or absence of gag and oculo-cephalic brain stem reflexes
- Patients with a history of allergy or intolerance to calcium channel blockers
- Patients with a history of allergy to soybean oil or egg lecithin
Show all 14Show fewer
- Patients who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to enrollment
- Patients who have acute myocardial infarction (AIM) on presentation
- Patients who have known or suspected aortic dissection
- Females who are pregnant or are breastfeeding
- Patients with a history of liver failure, cirrhosis or pancreatitis
- Patients with a prior directive against advanced life support
- Patients with a history of impaired lipid metabolism
- Patients with a history of severe aortic stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
Read the detailed description
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
All patients in which ICP monitoring is carried out need to maintain Cerebral Perfusion Pressure (CPP) within a tight range (typically, 70-90 mmHg) in order to avoid secondary brain injuries related to either too high or too low CPP. In this context there are clear benefits associated with a medication that is able to control hypertensive situations quickly and that lends itself to easy and reliable modulation.
Clinical studies have demonstrated that Clevidipine is an effective antihypertensive agent with a rapid onset and offset of action, and a favorable safety profile. Clevidipine has a predictable dose-response profile and is readily titrated to achieve individualized pharmacodynamic effects.
The investigators reasoned that Clevidipine could be an effective anti-hypertensive agent in this cohort of patients in which there is a need for rapid and precise blood pressure control. It is further hypothesized that improved blood pressure control in this patient population may result in the reduction in the severity of their neurological impairment.
The question to be answered is as follows: Is Clevidipine highly effective in achieving and maintaining Blood Pressure control in patients with hypertension (Systolic Blood Pressure > 160 mm Hg) and who require an Intracranial Pressure Monitoring Device?
Clevidipine will be highly effective in achieving and maintaining Blood Pressure control in patients with hypertension and who require an Intracranial Pressure Monitoring Device.
- Conditions
- Hypertension
- Being tested
- Clevidipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevidipineDrug
Clevidipine for the treatment of acute hypertension defined SBP > 160 mmHg in patients who require an Intracranial Pressure Monitoring Device
| Study group | Role | What they receive |
|---|---|---|
| Clevidipine | Experimental | Using Clevidipine for the treatment of acute hypertension defined SBP > 160 mmHg in patients who require an Intracranial Pressure Monitoring Device Receives: Drug: Clevidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve target Systolic Blood Pressure within 30 minutes of start of Celevidipine infusion
To evaluate the efficacy of Clevidipine for the treatment of acute hypertension during the first 30 minutes after initiation of the intravenous infusion in patients who require an Intracranial Pressure Monitoring Device
Measured: Up to 1 year
Secondary outcomes (2)
Percentage of patients who reach target Systolic Blood Pressure within 30 minutes of start of Clevidipine infusion
To evaluate the efficacy of Clevidipine to maintain Systolic Blood Pressure (SBP) within the target range after the first 30 minutes of an initial infusion and up to 3 hours in patients who required an Intracranial Pressure Monitoring
Measured: Up to 1 year
Percentage of patients in who the Systolic Blood Pressure is maintained within the target range for up to 3 hours after the first 30 minutes of the start of Clevidipine infusion
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startApr 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Sponsor discontinued the research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Ammirati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Ammirati, Ohio State University
- Investigators
- Mario Ammirati, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910532
- Sponsor's protocol ID
- 2009H0336
- Status last verified
- Jul 2013
- First submitted
- 19 Dec 2011
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
- ClinicalTrials.gov ID
- NCT01910532
- Acronym / sponsor ID
- 2009H0336
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor discontinued the research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mario AmmiratiUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
Detailed description
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring device.
All patients in which ICP monitoring is carried out need to maintain Cerebral Perfusion Pressure (CPP) within a tight range (typically, 70-90 mmHg) in order to avoid secondary brain injuries related to either too high or too low CPP. In this context there are clear benefits associated with a medication that is able to control hypertensive situations quickly and that lends itself to easy and reliable modulation.
Clinical studies have demonstrated that Clevidipine is an effective antihypertensive agent with a rapid onset and offset of action, and a favorable safety profile. Clevidipine has a predictable dose-response profile and is readily titrated to achieve individualized pharmacodynamic effects.
The investigators reasoned that Clevidipine could be an effective anti-hypertensive agent in this cohort of patients in which there is a need for rapid and precise blood pressure control. It is further hypothesized that improved blood pressure control in this patient population may result in the reduction in the severity of their neurological impairment.
The question to be answered is as follows: Is Clevidipine highly effective in achieving and maintaining Blood Pressure control in patients with hypertension (Systolic Blood Pressure > 160 mm Hg) and who require an Intracranial Pressure Monitoring Device?
Clevidipine will be highly effective in achieving and maintaining Blood Pressure control in patients with hypertension and who require an Intracranial Pressure Monitoring Device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clevidipine | Experimental | Drug: ClevidipineUsing Clevidipine for the treatment of acute hypertension defined SBP > 160 mmHg in patients who require an Intracranial Pressure Monitoring Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years or older
- Written informed consent from the patient or their legal representative family member before initiation of any study-related procedures
- Patients who clinically require Intracranial Pressure Monitoring device
- Patients who have baseline systolic blood pressure (SBP) (immediately prior to initiation of Clevidipine) > 160 mmHg measured using an arterial line
- Patients who required IV antihypertensive therapy to achieve SBP ≤ 160 mm Hg
Key exclusion criteria (14 listed)
- Patients who are prisoners
- Patients who received an oral antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who received any other IV antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who have fixed dilated pupils and/or absence of gag and oculo-cephalic brain stem reflexes
- Patients with a history of allergy or intolerance to calcium channel blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClevidipineClevidipine for the treatment of acute hypertension defined SBP > 160 mmHg in patients who require an Intracranial Pressure Monitoring Device | Drug | Clevidipine |
Primary outcome
Time to achieve target Systolic Blood Pressure within 30 minutes of start of Celevidipine infusion
Time frame: Up to 1 year
To evaluate the efficacy of Clevidipine for the treatment of acute hypertension during the first 30 minutes after initiation of the intravenous infusion in patients who require an Intracranial Pressure Monitoring Device
2 secondary outcomes
Percentage of patients who reach target Systolic Blood Pressure within 30 minutes of start of Clevidipine infusion
Time frame: Up to 1 year
Percentage of patients in who the Systolic Blood Pressure is maintained within the target range for up to 3 hours after the first 30 minutes of the start of Clevidipine infusion
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Ammirati, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clevidipine in people with Hypertension, run by Mario Ammirati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve target Systolic Blood Pressure within 30 minutes of start of Celevidipine infusion (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.