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NCT03051282 · ClinicalTrials.gov registry record · Phase 4
Genetic Determinants of ACEI Prodrug Activation
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT03051282 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 21 participants.
The verdict
NCT03051282, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
Angiotensin-converting enzyme inhibitors (ACEIs) are among the most frequently prescribed medications worldwide for the treatment of essential hypertension, left ventricular systolic dysfunction, acute myocardial infarction, and prevention of the progression of diabetic nephropathy. However, the outcome of ACEI treatment varies significantly between individuals and selected populations. Suboptimal response, therapeutic failure, and significant side effects are commonly documented in patients receiving ACEI therapy. Approximately 80% of the ACEIs available for use in the US are synthesized as esterified prodrugs in order to improve otherwise poor oral bioavailability of the active molecule. The activation of ACEI prodrugs primarily occurs in the liver via metabolic de-esterification of the parent drug. The critical activation step is essential in delivering a successful therapeutic outcome since the active metabolites are approximately 10-1000 times more potent relative to their respective parent compounds. Carboxylesterase 1 (CES1), the most abundant hydrolase in the liver, is responsible for the activation of ACEI prodrugs in humans. Marked interindividual variability in CES1 expression and activity has been documented, which results in varied therapeutic efficacy and tolerability of many drugs serving as substrates of CES1. Genetic variation of CES1 is considered to be a major factor contributing to variability in CES1 function. The study team proposes to conduct a multiple-dose healthy volunteer study to evaluate the impact of CES1 genetic variation on the activation, pharmacokinetics, and pharmacodynamics of enalapril, a model ACEI prodrug activated by CES1. The completion of this study will represent a major step towards the establishment of an evidence base from which a more individualized use of ACEI prodrugs can emerge.
Interventions
- DRUG Enalapril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03051282
The ClinicalTrials.gov registry entry for NCT03051282 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enalapril is the first listed.
NCT03051282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03051282 about?
NCT03051282 is a clinical study titled "Genetic Determinants of ACEI Prodrug Activation". Angiotensin-converting enzyme inhibitors (ACEIs) are among the most frequently prescribed medications worldwide for the treatment of essential hypertension, left ventricular systolic dysfunction, acute myocardial infarction, and prevention of the progression of diabetic nephropathy. However, the out...
What is the current status of trial NCT03051282?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2017-04-01. Estimated completion is 2026-01-01.
What interventions are being tested in trial NCT03051282?
The interventions under investigation include: Enalapril (DRUG).
Who is sponsoring clinical trial NCT03051282?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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