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Calcium Channel Blocker
High-Concentration IV Nicardipine for Stroke-Related Conditions
Phase 4
Waitlist Available
Led By David Wang, DO
Research Sponsored by OSF Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test if a higher concentration of Nicardipine, given through IV, is effective and safe in patients with stroke, intracerebral hemorrhage or subarachnoid hemorrhage.
Who is the study for?
This trial is for adults over 18 with acute ischemic or hemorrhagic stroke and high blood pressure needing control, possibly for thrombolytic or anticoagulation therapy. It's not for those with severe liver issues, pregnant/nursing women, people enrolled in other studies, previous participants, those allergic to Nicardipine, with severe heart dysfunction or advanced kidney failure.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of using double or triple concentrated IV Nicardipine to manage hypertension in stroke patients. This could reduce the fluid volume needed compared to standard treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions to IV medication such as irritation at the infusion site. Since it's a blood pressure medication, there might be risks of too low blood pressure like dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke caused by bleeding in my brain and may need blood pressure management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
• Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.
Secondary outcome measures
Safety
Time and dosage adjustment needed to reach the target BP range
To evaluate the tolerance of the double or triple concentrated Nicardipine
Find a Location
Who is running the clinical trial?
PDL BioPharma, Inc.Industry Sponsor
12 Previous Clinical Trials
1,147 Total Patients Enrolled
OSF Healthcare SystemLead Sponsor
29 Previous Clinical Trials
33,626 Total Patients Enrolled
David Wang, DOPrincipal InvestigatorOSF Stroke Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are twice the normal level.I or my representative have not refused to join this study.I am 18 years old or older.My kidney function is impaired, or my creatinine levels are above 2.0.You are allergic to Nicardipine or have had a bad reaction to it in the past.My heart's pumping ability is significantly reduced.I had a stroke and my high blood pressure is hard to control.I had a stroke caused by bleeding in my brain and may need blood pressure management.My condition is advanced aortic stenosis.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots to participate in this research endeavor?
"Clinicaltrials.gov's records indicate that the trial, which was initially launched on January 1st 2004 and edited lastly in May 12th 2006 is not actively recruiting patients. Unfortunately, no participants can be enrolled at this time; however there are 745 other medical studies still searching for volunteers."
Answered by AI
Is the upper age limit for this trial beyond sixty years?
"According to the study requirements, individuals aged 18 or over may participate but must not exceed 65 years old."
Answered by AI
Has this therapy attained the approval of the Federal Drug Administration?
"There is a wealth of data affirming the safety profile of this treatment, so it has been awarded an assessment score of 3 by our Power team. As Phase 4 trials are approved for public use, we can expect that the medication is safe to administer."
Answered by AI
Might I be eligible to join this research endeavor?
"This medical trial seeks 50 participants who suffer from hypertension and are aged 18 or above. Applicants must fulfill the following requirements: Male, Female, or Non-Binary; Eighteen years of age or older."
Answered by AI
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