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NCT02417246 · ClinicalTrials.gov registry record · Phase 4
Open-Labeled PK-PD Studies of Metoprolol ER
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT02417246 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 61 participants.
The verdict
NCT02417246, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
Recently, the quality of generic metoprolol extended-release (ER) products has been called into question with reports of inconsistent effects when switching from the brand name product to a generic formulation. Problems with how the body processes these drugs could have serious and widespread consequences given the high frequency of metoprolol ER use in the management of various cardiovascular disorders, including high blood pressure, coronary heart disease, heart failure, and cardiac arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead to variability in the way the body breaks down the drug (pharmacokinetics) and clinical response to generic versus name brand metoprolol ER formulations. Investigators will study the brand name and generic metoprolol ER formulations in subjects with high blood pressure to compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses of each product (brand name and two approved generics). The study objective is to provide information on how the body breaks down generic and brand name metoprolol ER products (pharmacokinetics) and how the body responds to generic and brand name metoprolol ER products (pharmacodynamics) to better understand if generic metoprolol ER products are as good as the brand name product.
Interventions
- DRUG brand name metoprolol ER
- DRUG Generic A
- DRUG Generic B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-06-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02417246
The ClinicalTrials.gov registry entry for NCT02417246 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which brand name metoprolol ER is the first listed.
NCT02417246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02417246 about?
NCT02417246 is a clinical study titled "Open-Labeled PK-PD Studies of Metoprolol ER". Recently, the quality of generic metoprolol extended-release (ER) products has been called into question with reports of inconsistent effects when switching from the brand name product to a generic formulation. Problems with how the body processes these drugs could have serious and widespread conseq...
What is the current status of trial NCT02417246?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2015-08. Estimated completion is 2018-06-06.
What interventions are being tested in trial NCT02417246?
The interventions under investigation include: brand name metoprolol ER (DRUG), Generic A (DRUG), Generic B (DRUG).
Who is sponsoring clinical trial NCT02417246?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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