Subarachnoid HemorrhageNCT00490464
Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH
An observational study of Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- What is being tested?
- Nicardipine and Nipride
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2007
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old (inclusive)
- Admission to NSICU with a diagnosis of SAH or ICH
Who cannot join
- Patients who are admitted >48 hours after SAH or ICH
- Readmission or second SAH
- Readmission or second ICH
- Large (immediately life threatening) associated intraparenchymal or intraventricular hemorrhage
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago, UIC
Chicago, Illinois, 60612
About this study
The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.
- Conditions
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- Being tested
- Nicardipine and Nipride
- Keywords
- Patients with SAH or ICH
- Medical subject headings
- Subarachnoid Hemorrhage, Cerebral Hemorrhage, Hepatitis, Infectious Canine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicardipine and NiprideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJun 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Investigators
- Ben Z Roitberg, MD, Principal investigator, University of Illinois at Chicago, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490464
- Sponsor's protocol ID
- 2004-0233
- Status last verified
- Jun 2007
- First submitted
- 20 Jun 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH
- ClinicalTrials.gov ID
- NCT00490464
- Acronym / sponsor ID
- 2004-0233
- Conditions
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- Keywords
- Patients with SAH or ICH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 22 Jun 2007 (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.
The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 years old (inclusive)
- Admission to NSICU with a diagnosis of SAH or ICH
Key exclusion criteria (5 listed)
- Patients who are admitted >48 hours after SAH or ICH
- Readmission or second SAH
- Readmission or second ICH
- Large (immediately life threatening) associated intraparenchymal or intraventricular hemorrhage
- Women who are pregnant
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 |
|---|---|---|
| Nicardipine and Nipride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
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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.
Ben Z Roitberg, MD principal investigator
University of Illinois at Chicago, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by University of Illinois Chicago 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2007. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Jun 2007.