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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measurements of the mean area under the curve (AUC) of enalaprilat plasma concentrations
Secondary outcome measures
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

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
1,795 Previous Clinical Trials
6,373,915 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications for participating in this medical experiment?

"In order to qualify, volunteers must be in good health and aged between 18-55. 21 individuals will eventually make up the entire study sample size."

Answered by AI

What ailments are G143E carriers typically prescribed for?

"G143E carriers group is primarily prescribed to treat hypertension that cannot be managed with single-drug therapy. It can also assist those struggling with congestive heart failure, asymptomatic left ventricular dysfunction and other cardiovascular diseases."

Answered by AI

Is this experiment including geriatric individuals in its sample size?

"The parameters of this clinical trial require that participants are between 18 and 55 years old. Patients below the age of 18 can look for 53 alternative studies, while those over 65 could find 368 other options."

Answered by AI

Is the G143E carriers group a safe population to interact with?

"G143E carriers group was assigned a score of 3, as it is currently in the fourth stage of clinical trials and has been given official approval."

Answered by AI

How many patients is the research team recruiting for this experiment?

"This medical trial is not presently enrolling patients, as the study was last updated on February 6th 2023. If you are looking for other studies to join, there are 809 clinical trials recruiting healthy participants and 12 more specifically seeking G143E carriers."

Answered by AI

Is there capacity to enroll additional volunteers in this research endeavor?

"The clinical trial indicated by the information on clinicaltrials.gov is no longer seeking participants; it was posted in April 2017 and last updated in February 2023. However, there are currently 821 other trials actively recruiting patients."

Answered by AI

Are there any additional investigations involving individuals with the G143E gene mutation?

"At the moment, 12 studies of G143E carriers are in progress with 5 trials being conducted on a Phase 3 basis. Most of these clinical experiments for G143E carriers take place near Ann Arbor, Michigan and 399 other locations offer medical research for this group."

Answered by AI

Who else is applying?

What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I thought it was a Paid Study and I'm a Healthy Volunteer.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Genetic Determinants of ACEI Prodrug Activation
Haojie Zhu 2017. "Genetic Determinants of ACEI Prodrug Activation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03051282.
~4 spots leftby Jan 2026
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