Minocycline for High Blood Pressure

Recruiting at 1 trial location

Overseen By Sarah Long, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Thiazide diuretics

Must not be taking: Oral antibiotics

Disqualifiers: Secondary hypertension, Myocardial infarction, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how minocycline, an antibiotic, might aid individuals with high blood pressure unresponsive to other treatments. Researchers aim to determine if minocycline can lower blood pressure and its potential mechanisms, particularly regarding gut health and inflammation. Participants will take either minocycline or a placebo daily for three months. This trial may suit adults with difficult-to-control high blood pressure, despite trying at least three different medications. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable blood pressure medication regimen for at least 30 days before joining. You should discuss your specific medications with the trial team.

What is the safety track record for minocycline?

Research has shown that minocycline, an antibiotic, is generally safe for people. The FDA has approved it for treating various infections. Studies have found that most people tolerate it well, although some might experience side effects. Common side effects include dizziness, nausea, and skin reactions. A rare but serious side effect is increased pressure in the head, known as intracranial hypertension, which is more likely in women of childbearing age.

Previous patients using different doses of minocycline demonstrated its safety when properly monitored. Since this trial is in an advanced phase, minocycline has been deemed safe enough to further test its effects on blood pressure. Always consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard blood pressure treatments, such as ACE inhibitors, beta-blockers, and diuretics, Minocycline offers a unique approach by potentially tapping into its anti-inflammatory properties. Researchers are excited about Minocycline because it might address high blood pressure through mechanisms beyond traditional pathways, possibly offering an alternative for patients who don't respond well to existing medications. Its dual action as an antibiotic and anti-inflammatory could provide unexpected cardiovascular benefits, setting it apart from current options.

What is the effectiveness track record for minocycline in treating high blood pressure?

Research shows that minocycline, an antibiotic, might help lower blood pressure in people with treatment-resistant hypertension. Earlier studies found that minocycline significantly reduced blood pressure. Specifically, one study showed it improved resting systolic blood pressure (the top number in a blood pressure reading) compared to a group that did not receive the treatment. Minocycline may help by reducing inflammation, which can affect blood pressure control. These encouraging results suggest it could be useful for managing high blood pressure that doesn't respond well to other treatments. Participants in this trial will receive either minocycline hydrochloride or a placebo to evaluate its effectiveness in this context. ^{1 3 6 7 8}

Who Is on the Research Team?

Steven M Smith, PharmD, MPH

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My high blood pressure is not controlled despite taking three or more blood pressure medications.

Self-identify as White or African American

The participant agrees to have all study procedures performed

Exclusion Criteria

Current pregnancy or anticipated pregnancy during the study

Evidence of alcoholism or drug abuse

Known hypersensitivity or contraindication to minocycline or other tetracyclines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to receive either minocycline or placebo, administered twice daily for 3 months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood tests and neuroimaging for those in the substudy

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Minocycline

Trial Overview 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.

How Is the Trial Designed?

Group I: Minocycline Hydrochloride Experimental Treatment 1 Intervention

Minocycline hydrochloride 100 mg, administered twice daily for 3 months

Group II: Placebo Placebo Group 1 Intervention

Placebo administered twice daily for 3 months

Minocycline is already approved in United States, European Union, Japan, India for the following indications:

Approved in United States as Minocin for:

• Acne
• Bacterial infections
• Periodontal disease
• Rosacea

Approved in European Union as Minostad for:

• Acne

Approved in Japan as Minopen for:

• Bacterial infections

Approved in India as Minoz for:

• Bacterial infections

Approved in United States as Amzeeq for:

• Acne

Approved in United States as Zilxi for:

• Rosacea

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a study involving 56 oncology patients with vancomycin-resistant enterococci (VRE) infections, the combination of quinopristin-dalfopristin and minocycline showed a response rate of 68%, indicating its effectiveness against these infections.

The treatment was associated with a notable side effect, with 36% of patients experiencing arthralgia or myalgia, highlighting the need to consider potential adverse effects when using this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vancomycin-resistant enterococcal infections in the immunocompromised host: quinupristin-dalfopristin in combination with minocycline. Raad, I., Hachem, R., Hanna, H., et al.[2018]

The review covers various topical antibacterial medications commonly used in veterinary dermatology, including their pharmacokinetics, mechanisms of action, and potential side effects, providing a comprehensive understanding of their clinical applications.

General recommendations for the use of topical antibacterial therapy in treating conditions like canine and feline pyoderma are presented, emphasizing the importance of selecting the appropriate medication based on specific clinical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of canine and feline pyoderma. Guaguere, E.[2021]

Dalbavancin shows promise as an effective treatment for resistant Gram-positive infections in children, with advantages such as fewer doses needed and lower potential for drug interactions, based on a review of 36 studies and ongoing clinical trials.

However, more research is necessary to determine the appropriate dosage and safety of dalbavancin in pediatric patients before it can be widely used in newborns and children, especially given the rise of multidrug-resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalbavancin for the treatment of paediatric infectious diseases. Esposito, S., Bianchini, S.[2018]

Afabicin, a novel antibiotic targeting fatty acid synthesis in Staphylococcus spp., demonstrated comparable efficacy to vancomycin/linezolid in treating acute bacterial skin infections, with clinical response rates of 94.6% for low-dose afabicin and 90.1% for high-dose afabicin.

Both doses of afabicin were well tolerated, with mild side effects like headache and nausea, indicating its potential as a safe treatment option for staphylococcal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Wittke, F., Vincent, C., Chen, J., et al.[2022]

Quinupristin/dalfopristin demonstrated strong in-vitro activity against Staphylococcus aureus, inhibiting all methicillin-sensitive strains at a concentration of 1 mg/L and 75% of methicillin-resistant strains at 1.5 mg/L.

This antibiotic could serve as a promising alternative treatment for methicillin-resistant staphylococcal infections, potentially reducing reliance on glycopeptide antibiotics like vancomycin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative in vitro activity of quinupristin/dalfopristin and seven other antimicrobials against methicillin-susceptible and methicillin-resistant nosocomial Staphylococcus aureus bloodstream isolates. Nikolaidis, P., Metallidis, S., Katikaridou, E., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02133872

Study 1: Effect of Minocycline Treatment on Drug-Resistant ... This study is designed to evaluate a low and high dose of minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects ...

2. ahajournals.org ahajournals.org/doi/10.1161/hyp.68.suppl_1.p110

Abstract P110: Low Dose Minocycline Lowers BP and ... This study was to test the hypothesis that minocycline (Mino), an anti-inflammatory antibiotic, would lower BP and inflammatory markers in patient with TRH.

3. faseb.onlinelibrary.wiley.com faseb.onlinelibrary.wiley.com/doi/10.1096/fasebj.31.1_supplement.1077.4

Minocycline Partially Restores Blood Pressure Regulation ... We show that the acute administration of minocycline significantly improves resting systolic blood pressure (107±1.5mmHg) compared to vehicle (98±2.2mmHg).

4. withpower.com withpower.com/trial/phase-4-hypertension-resistant-to-conventional-therapy-3-2024-3c804

Minocycline for High Blood Pressure Trial Overview The study tests if minocycline can lower blood pressure in resistant cases over a 3-month period, compared to a placebo. It also explores ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554519/

Minocycline - StatPearls - NCBI Bookshelf Minocycline belongs to the tetracycline class of antibiotics and is used to manage and treat both infectious and non-infectious conditions.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf

Solodyn (minocycline hydrochloride) tablet label safe and effective in children under the age of 12 years. Who should not take SOLODYN®? Do not take SOLODYN® if you are allergic to tetracycline class drugs.

7. mayoclinic.org mayoclinic.org/drugs-supplements/minocycline-oral-route/description/drg-20075715

Minocycline (oral route) - Side effects & dosage This medicine may cause increased pressure inside the head (intracranial hypertension). This is more likely to occur in females of childbearing ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02802631

NCT02802631 | Study to Evaluate Safety, Tolerability, and ... The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data on ascending dose regimens of Minocin (minocycline) for Injection.