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ACE Inhibitor

Genetic Factors in Enalapril Activation for Healthy Subjects

Phase 4
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be male and female (50:50) between the ages of 18-55 years
Be between 18 and 65 years old
Must not have
The presence of a known medical condition that would preclude the use of enalapril
Asians will not be included in the study as the CES1 SNP G143E is absent in this population
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trialwill explore how genetic differences can influence how effective ACEI drugs are and how well they're tolerated by different people.

Who is the study for?
This trial is for healthy men and women aged 18-55, with a balanced gender ratio. Participants must not have significant diseases or abnormal lab results, be non-smokers, not pregnant, and use birth control if applicable. Asians are excluded due to genetic reasons related to the study's focus.
What is being tested?
The trial studies how genetic differences affect the body's ability to activate Enalapril, a common drug for high blood pressure and heart issues. It looks at how well different people process the drug because of their unique genes.
What are the potential side effects?
While this study involves healthy volunteers taking Enalapril, potential side effects can include coughing, dizziness due to low blood pressure, kidney problems, elevated potassium levels in the blood and rarely swelling of tissues (angioedema).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any conditions that prevent me from taking enalapril.
Select...
I am not Asian, as this study excludes Asians due to a specific genetic reason.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The measurements of the mean area under the curve (AUC) of enalaprilat plasma concentrations
Secondary study objectives
The measurements of angiotensin converting enzyme (ACE) activity in plasma
The measurements of blood pressures (BPs) following enalapril treatment
The measurements of the maximum enalaprilat plasma concentrations

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: non-carrier control groupActive Control1 Intervention
Subjects who do not carry the CES1 variant G143E (rs71647871) will receive 10 mg Enalapril orally once daily for 7 consecutive days.
Group II: G143E carriers groupActive Control1 Intervention
Subjects who carry the CES1 variant G143E (rs71647871) will receive 10 mg Enalapril orally once daily for 7 consecutive days.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,433,004 Total Patients Enrolled

Media Library

Enalapril (ACE Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03051282 — Phase 4
Healthy Subjects Research Study Groups: non-carrier control group, G143E carriers group
Healthy Subjects Clinical Trial 2023: Enalapril Highlights & Side Effects. Trial Name: NCT03051282 — Phase 4
Enalapril (ACE Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03051282 — Phase 4
~3 spots leftby Jan 2026
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