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Diuretic

Amiloride for Prehypertension (SAPHA Trial)

Phase 4
Waitlist Available
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female of Caucasian or African-American origin.
Not taking any medication that affects blood pressure.
Must not have
Female having positive pregnancy test during screening and/or any testing visit.
Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 50 ml/min* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test whether amiloride can improve vascular health in young adults with prehypertension.

Who is the study for?
This trial is for young Caucasian or African-American adults with slightly elevated blood pressure, known as prehypertension. Participants should not have major illnesses like diabetes or liver disease and must not be on blood pressure medication. Pregnant women and individuals with high HbA1C levels, potassium, or creatinine are excluded.
What is being tested?
The study aims to see if Amiloride can improve the health of blood vessels in young adults who have prehypertension but aren't yet at the stage where they need regular hypertension treatment.
What are the potential side effects?
Potential side effects of Amiloride include raising potassium levels which could affect heart rhythm, causing dehydration or low sodium levels, dizziness from lowered blood pressure, and possible kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either Caucasian or African-American.
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I am not on any blood pressure medications.
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I do not have any major illnesses like diabetes or liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, as confirmed by tests during screening.
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My kidney function is reduced, with creatinine levels high or clearance low.
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My potassium levels are higher than 5.5 mEq/L.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vascular phenotypes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AmilorideExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amiloride
FDA approved

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,658 Total Patients Enrolled
14 Trials studying Hypertension
2,129 Patients Enrolled for Hypertension

Media Library

Amiloride (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT01308983 — Phase 4
Hypertension Research Study Groups: Amiloride
Hypertension Clinical Trial 2023: Amiloride Highlights & Side Effects. Trial Name: NCT01308983 — Phase 4
Amiloride (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01308983 — Phase 4
~2 spots leftby Nov 2025
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