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Vasoconstrictor
Phenylephrine for Low Blood Pressure
Phase 4
Recruiting
Research Sponsored by West-Ward Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is scheduled for a procedure that requires general or neuraxial anesthesia
Subjects with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
Must not have
Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
Subjects taking antihypertensive medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is designed to study the effects of phenylephrine hydrochloride injection on blood pressure in adolescents undergoing general or neuraxial anesthesia.
Who is the study for?
This trial is for kids aged 12-16 who need anesthesia for a procedure and have low blood pressure. They should be generally healthy, not pregnant, and not on blood pressure meds. Kids with serious health issues or recent infections can't join.
What is being tested?
The study tests how Phenylephrine Hydrochloride Injection affects blood pressure in young patients under anesthesia. It looks at dosage effects, changes in heart rate and blood pressure, response times, safety, and how the body processes the drug.
What are the potential side effects?
Possible side effects of Phenylephrine may include rapid heartbeat, headache, nervousness, restlessness, nausea or vomiting; rare but more serious reactions could involve high blood pressure or irregular heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery that needs general or spinal anesthesia.
Select...
My diabetes is under control and my blood pressure is 128/78 mmHg or lower.
Select...
I am between 12 and 16 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take certain medications to control my blood pressure.
Select...
I am on medication for high blood pressure.
Select...
I am not pregnant, nursing, and I use effective birth control.
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PhenylephrineExperimental Treatment1 Intervention
Phenylephrine Hydrochloride Injection, USP (United States Pharmacopeia) 10 mg/mL label claim
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
FDA approved
Find a Location
Who is running the clinical trial?
West-Ward PharmaceuticalLead Sponsor
3 Previous Clinical Trials
1,921 Total Patients Enrolled
Cesar Ormeno, MDStudy DirectorPRA Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken a pregnancy test that was negative.I am not pregnant, nursing, and I use effective birth control.I am scheduled for surgery that needs general or spinal anesthesia.I cannot take certain medications to control my blood pressure.I haven't had a serious infection in the last 4 weeks.I am on medication for high blood pressure.My diabetes is under control and my blood pressure is 128/78 mmHg or lower.I do not have any serious health issues that could affect my participation in the study.The person is very sick and is expected to pass away within two days.You have hepatitis B or C.I am between 12 and 16 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Phenylephrine
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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