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Upstate Active Clinical Trials

Study Title:

Asystole from intravenous metoprolol: applying clinical pharmacology principles to drug safety

What is the purpose of the study?

To collect data about heart rate, blood pressure and blood concentrations of metoprolol after the intravenous administration of undiluted and diluted metoprolol given over 5 and 15 minutes in healthy adult subjects.

Upstate Institutional Review Board (IRB) Number:

432037

Study Phase:

4

Patient Age Group:

Adults

Principal Investigator:

David F Lehmann

Who is eligible?

Male or female; age between 18-65 years; weight within 30% ideal body weight; normal healthy volunteers with a baseline normal electrocardiogram. All subjects will be caffeine free for 12 hours prior to drug administration; Baseline heart rate > 50 bpm and Systolic BP >90 mmHg

What is involved if I participate?

  • How long is the study?
    One screening visit (30min), two infusion visits (7am-4pm, scheduled at least one full week apart)
  • Is transportation provided or reimbursed?
    No
  • Is parking provided or reimbursed?
    No
  • What tests and procedures are involved?
    ECG, Blood samples, insertion of two small intravenous (IV) tubes (one in each arm). These tubes will be used to give you the study drug and to obtain blood samples at regular intervals during the study visit.

Where will the study take place?

SUNY Upstate Medical University, Institute for Human Performance, Clinical Research Unit, 505 Irving Ave., Syracuse, NY 13210

Other Information:

Payments
There are no costs to you and/or your insurance carrier for participating in this study.
If you qualify to participate after the initial screening, you will be compensated for your participation by payment in the amount of $100.00. Subjects who withdraw early (after the first infusion session) will be compensated half that amount ($50).

Who can I contact for more information?

Name: Mia Ruiz-Salvador
Phone: 315-464-5367
Email: ruizsalm@upstate.edu

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