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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: Completed Phase 4 study, sponsored by University of Florida.
NCT02417246 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The AUC of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and standard deviation (SD) values of AUC are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.
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 |
What the finished NCT02417246 record still lists
NCT02417246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which brand name metoprolol ER is the first listed.
NCT02417246 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02417246's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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