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New treatment option for Hypotension
Official title Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
ClinicalTrials.gov ID: NCT02323399
What this study is testing
What is Phenylephrine?
Phenylephrine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypotension.
Also referred to as Phenylephrine Hydrochloride Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 16. Healthy volunteers may be eligible.
You may be able to join if
- Subject's age is between ≥12 and 16 years, inclusive
- Subject is scheduled for a procedure that requires general or neuraxial anesthesia
- people must have normal or clinically acceptable physical exam
- people with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of...
- Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
You likely can't join if
- Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
- Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
- Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
- people who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment...
- people who are positive for hepatitis B surface antigen or hepatitis C antibody
- people taking antihypertensive medication
See the full eligibility criteria
- Subject's age is between ≥12 and 16 years, inclusive
- Subject is scheduled for a procedure that requires general or neuraxial anesthesia
- people must have normal or clinically acceptable physical exam
- people with controlled diabetes prior to entry must have a mean systolic/diastolic office blood pressure ≤128/78 mmHg (sitting, after 5 minutes of rest)
- Females must have a urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1
- Subject's parent or legal guardian gives informed consent and subject gives assent.
- Subject has a contraindication to vasoconstrictor therapy for control of blood pressure
- Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
- Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
- people who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration
- people who are positive for hepatitis B surface antigen or hepatitis C antibody
- people taking antihypertensive medication
- Subject is moribund (death is likely to occur in less than 48 hours)
- Females who are pregnant, nursing or unwilling to use/practice adequate contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Jackson, Mississippi, United States
- Stony Brook, New York, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 16 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilmington, Delaware, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Jackson, Mississippi, United States; Stony Brook, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.