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Anti-inflammatory

Minocycline for High Blood Pressure

Phase 4
Waitlist Available
Led By Steven M Smith, PharmD, MPH
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Uncontrolled TRH, defined as uncontrolled blood pressure (mean 24-hour ambulatory systolic BP ≥125 mm Hg or diastolic BP ≥80 mm Hg) while being adherent to a stable (no changes in ≥30 days prior) antihypertensive regimen of 3 or more drugs, including an adequately dosed thiazide or thiazide-like diuretic (hydrochlorothiazide ≥25 mg/day or equivalent)
Age ≥18 years
Must not have
History of antihypertensive crisis, defined as any in-patient hospitalizations for antihypertensive crisis/emergency within the past year
Recent (≤3 months prior), ongoing, or expected use of oral antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to understand how minocycline affects blood pressure in people with treatment-resistant hypertension. It will investigate the extent to which minocycline lowers blood pressure and whether this effect varies among

Who is the study for?
This trial is for individuals with high blood pressure that doesn't get better with treatment. Participants will be studied to see how minocycline affects their condition, considering factors like race and changes in gut health.
What is being tested?
The study tests if minocycline can lower blood pressure in resistant cases over a 3-month period, compared to a placebo. It also explores whether the effects are due to changes in gut bacteria, inflammation or other factors.
What are the potential side effects?
Minocycline may cause side effects such as dizziness, fatigue, gastrointestinal issues, skin reactions and possibly affect the balance of gut bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My high blood pressure is not controlled despite taking three or more blood pressure medications.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been hospitalized for a severe high blood pressure crisis in the last year.
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I have taken, am taking, or will take antibiotics in the last 3 months.
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My high blood pressure is caused by another health condition.
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I have had episodes where my blood pressure dropped significantly when standing up.
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I do not have severe illnesses like cancer or HIV/AIDS.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24-h systolic blood pressure
Gut inflammation and leakiness
Gut microbiome
+1 more
Secondary study objectives
24-h diastolic blood pressure
24-h heart rate
Adverse Events
+3 more

Side effects data

From 2016 Phase 2 trial • 47 Patients • NCT02297412
9%
Fatigue
9%
Lymphocyte count decreased
5%
Abdominal pain
5%
Thromboembolic event
5%
Diarrhea
5%
Back pain
5%
Dizziness
5%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Minocycline Hydrochloride)
Arm II (Placebo)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Minocycline HydrochlorideExperimental Treatment1 Intervention
Minocycline hydrochloride 100 mg, administered twice daily for 3 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered twice daily for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minocycline Hydrochloride
2018
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,773 Total Patients Enrolled
498 Trials studying Hypertension
2,741,272 Patients Enrolled for Hypertension
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,103 Total Patients Enrolled
34 Trials studying Hypertension
58,041 Patients Enrolled for Hypertension
Emory UniversityOTHER
1,708 Previous Clinical Trials
2,607,364 Total Patients Enrolled
31 Trials studying Hypertension
16,003 Patients Enrolled for Hypertension
Steven M Smith, PharmD, MPHPrincipal InvestigatorUniversity of Florida
~80 spots leftby Jul 2028
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