HypertensionPhase 4NCT01042574
The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy
A Phase 4 study testing Clevidipine butyrate in people with Hypertension and Intracranial Hemorrhage, run by Methodist Healthcare - Memphis at 1 site in United States.
Trial summary
This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Intracranial Hemorrhage, Subarachnoid Hemorrhage
- What is being tested?
- Clevidipine butyrate
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 31 Dec 2010
- 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
- Age 18 years or older
- Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
- Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
- Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg
- Patients with a life expectancy of > 5 hours.
- Written informed consent from the patient or their legal representative before initiation of any study specific procedures
Who cannot join
- Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
- Receipt of IV nicardipine
- Glasgow coma score (GCS) of <5 and fixed dilated pupils
- Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
- Known or suspected aortic dissection
- Acute myocardial infarction (AMI) on presentation
Show all 14Show fewer
- Positive pregnancy test , known pregnancy or nursing mother
- Intolerance or allergy to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Known liver failure, cirrhosis or pancreatitis
- Defective lipid metabolism
- Severe aortic stenosis
- Prior directives against advanced life support
- Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Healthcare, University Hospital
Memphis, Tennessee, 38104
About this study
Official title: The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
This study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).
Read the detailed description
Inclusion Criteria:
The study population will be comprised of men and non-pregnant women age 18 years or older presenting with ICH or SAH that require ICP monitoring via ventriculostomy, and that require IV antihypertensive therapy to a) reduce the risk re-bleeding in SAH and b) reduce the risk of hematoma expansion over time due to further bleeding.
This study population will require rapid and sustained tight control of blood pressure between 110 to 140 mmHg.
Subjects may be included in the study if they meet all of the following criteria:
- Age 18 years or older
- Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
- Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
- Requires IV antihypertensive therapy to achieve SBP 110 - 140 mmHg
- Patients with a life expectancy of > 5 hours.
- Written informed consent from the patient or their legal representative before initiation of any study specific procedures
Exclusion Criteria:
Subjects will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
- Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
- Receipt of IV nicardipine
- Glasgow coma score (GCS) of <5 and fixed dilated pupils
- Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
- Known or suspected aortic dissection
- Acute myocardial infarction (AMI) on presentation
- Positive pregnancy test , known pregnancy or nursing mother
- Intolerance or allergy to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Known liver failure, cirrhosis or pancreatitis
- Defective lipid metabolism
- Severe aortic stenosis
- Prior directives against advanced life support
- Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment
Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
- Being tested
- Clevidipine butyrate
- Keywords
- intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), intracranial monitoring, external ventricular drain (ventriculostomy), hypertension
- Medical subject headings
- Hypertension, Intracranial Hemorrhages, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevidipine butyrateDrug
Also called Cleviprex
Cleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this trial is the time to achieve the pre-specified SBP target range (110-140) within 30 minutes of the initiation of Cleviprex infusion.
Measured: 30 minutes
Secondary outcomes (1)
The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startMay 2010
- Primary completion31 Dec 2010 (estimated)
- Study completion31 Dec 2010
Why it stopped: Unable to secure funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Methodist Healthcare - Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- The Medicines Company
- Responsible party
- Sponsor
- Investigators
- Christopher K Finch, PharmD, Principal investigator, Methodist Healthcare, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042574
- Sponsor's protocol ID
- Cleviprex Use In ICB Patients
- Status last verified
- Mar 2018
- First submitted
- 4 Jan 2010
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009 Mar;53(3):329-38. doi: 10.1016/j.annemergmed.2008.04.025. Epub 2008 Jun 5.
PubMed 18534716
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT01042574
- Acronym / sponsor ID
- Cleviprex Use In ICB Patients
- Keywords
- intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), intracranial monitoring, external ventricular drain (ventriculostomy), hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Healthcare - MemphisUniversity, hospital or other
- Collaborators
- The Medicines Company
- Study start
- May 2010
- Primary completion
- 31 Dec 2010 (estimated)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 5 Jan 2010 (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 study is a single-arm, open label protocol evaluating the use of Cleviprex to rapidly control hypertension in patients who present with intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH), and that require ICP monitoring via ventriculostomy (External Ventricular Drain or EVD).
Detailed description
Inclusion Criteria:
The study population will be comprised of men and non-pregnant women age 18 years or older presenting with ICH or SAH that require ICP monitoring via ventriculostomy, and that require IV antihypertensive therapy to a) reduce the risk re-bleeding in SAH and b) reduce the risk of hematoma expansion over time due to further bleeding.
This study population will require rapid and sustained tight control of blood pressure between 110 to 140 mmHg.
Subjects may be included in the study if they meet all of the following criteria:
- Age 18 years or older
- Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
- Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
- Requires IV antihypertensive therapy to achieve SBP 110 - 140 mmHg
- Patients with a life expectancy of > 5 hours.
- Written informed consent from the patient or their legal representative before initiation of any study specific procedures
Exclusion Criteria:
Subjects will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
- Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
- Receipt of IV nicardipine
- Glasgow coma score (GCS) of <5 and fixed dilated pupils
- Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
- Known or suspected aortic dissection
- Acute myocardial infarction (AMI) on presentation
- Positive pregnancy test , known pregnancy or nursing mother
- Intolerance or allergy to calcium channel blockers
- Allergy to soybean oil or egg lecithin
- Known liver failure, cirrhosis or pancreatitis
- Defective lipid metabolism
- Severe aortic stenosis
- Prior directives against advanced life support
- Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment
Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Patient presentation with ICH or SAH, and that require ICP monitoring via ventriculostomy drain.
- Baseline systolic blood pressure (immediately prior to initiation of Cleviprex) >160 mmHg measured
- Requires IV antihypertensive therapy to achieve SBP 110 to 140 mmHg
- Patients with a life expectancy of > 5 hours.
Key exclusion criteria (14 listed)
- Receipt of an oral antihypertensive within 2 hours prior to initiation of Cleviprex
- Receipt of IV nicardipine
- Glasgow coma score (GCS) of <5 and fixed dilated pupils
- Expectation that the patient will not tolerate or require > 5 hours of concurrent Cleviprex treatment and ICP monitoring
- Known or suspected aortic dissection
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 |
|---|---|---|
| Clevidipine butyrateAlso: CleviprexCleviprex will be administered according to current package insert instructions, with a starting dose of 2.0mg/hr for 1.5 minutes and thereafter titrated to lower blood pressure to a target goal of 110 mmHG to 140mmHG. | Drug | – |
Primary outcome
The primary endpoint of this trial is the time to achieve the pre-specified SBP target range (110-140) within 30 minutes of the initiation of Cleviprex infusion.
Time frame: 30 minutes
1 secondary outcome
The percentage of patients whose SBP is <90 mmHg within 30 minutes of the initiation of Cleviprex infusion
Time frame: 30 minutes
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 14 Aug 2019.
- Background: PubMed 18534716Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009 Mar;53(3):329-38. doi: 10.1016/j.annemergmed.2008.04.025. Epub 2008 Jun 5.
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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.
Christopher K Finch, PharmD principal investigator
Methodist Healthcare, University Hospital
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 butyrate in people with Hypertension and Intracranial Hemorrhage, run by Methodist Healthcare - Memphis 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 6 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 14 Aug 2019. 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?
The primary endpoint of this trial is the time to achieve the pre-specified SBP target range (110-140) within 30 minutes of the initiation of Cleviprex infusion. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042574, which also lists 1 linked publication.
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 14 Aug 2019.