Terazosin for Healthy Adults

Overseen By Jordan Schultz, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Iowa

Must not be taking: Alpha blockers, Yohimbe, others

Disqualifiers: Stroke, Type I diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of a drug called Terazosin in healthy adults. The main goal is to observe how Terazosin interacts with the body using advanced imaging techniques like PET/CT and MRI scans. Participants will gradually increase their dose over five weeks. This trial suits individuals aged 60 to 90 who are generally healthy and not taking certain heart or blood pressure medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you are not currently using more than one medication from the following classes: beta blockers, ace inhibitors, angiotensin receptor blockers, calcium channel blockers, or diuretics. You also cannot have used alpha blockers in the past year or be using the supplement yohimbe.

Is there any evidence suggesting that Terazosin is likely to be safe for humans?

Research has shown that terazosin is generally well-tolerated. It is already used to treat high blood pressure and an enlarged prostate. Past studies identified dizziness and headaches as common side effects, which are usually mild. This trial, in its early phase, focuses on how terazosin works in the body rather than proving its safety, so fewer people have tried it in this setting. However, its current use for other conditions suggests it is reasonably safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for conditions like high blood pressure work by directly lowering blood pressure through mechanisms such as diuretics, beta-blockers, or ACE inhibitors. However, terazosin stands out because it targets the alpha-1 adrenergic receptors, which help to relax certain muscles and improve blood flow. Researchers are excited about terazosin because it not only has a different mechanism of action compared to traditional treatments, but it also offers the potential for additional benefits, such as improving urinary flow in conditions like benign prostatic hyperplasia. This dual action could make it a versatile option for patients needing treatment for both hypertension and prostate issues.

What evidence suggests that Terazosin might be an effective treatment for healthy adults?

Research has shown that Terazosin effectively treats conditions like benign prostatic hyperplasia (BPH), which means an enlarged prostate, and mild high blood pressure. Studies have found that Terazosin eases urinary symptoms related to BPH and lowers blood pressure in individuals with mild hypertension. Additionally, evidence suggests that the medication improves the flexibility of blood vessels, which is important for heart health. These findings support its potential benefits in managing these conditions. However, this study focuses on how Terazosin works in the bodies of healthy adults, rather than treating specific conditions. Participants in this trial will receive titrating doses of Terazosin, starting at 1mg daily and increasing to 5mg daily on a weekly basis for five weeks. ^{1 4 6 7 8}

Who Is on the Research Team?

Jordan Schultz, PharmD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged between 60-90 years old. The details about what might exclude someone from participating are not provided, but typically would involve factors that could affect the safety of participants or the results of the study.

Inclusion Criteria

I am between 60 and 90 years old and in good health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive titrating doses of terazosin starting at 1mg daily and increasing to 5mg daily on a weekly basis for five weeks

5 weeks

Weekly visits for dose adjustment and assessments

Assessment

Participants undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and optional lumbar puncture to assess target engagement and ATP levels

Throughout the 37-day study

Multiple visits for imaging and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Terazosin

Trial Overview The study is testing Terazosin (TZ) in a small group of 6 healthy adults to see how well it engages with its target in the body. Participants will undergo advanced imaging tests like PET/CT scans and high-field MRI, along with blood tests, and may choose to have a spinal tap procedure.

How Is the Trial Designed?

Group I: Primary Cohort Experimental Treatment 1 Intervention

Titrating doses of terazosin starting at 1mg daily and increasing to 5mg daily on a weekly basis for five weeks.

Terazosin is already approved in United States for the following indications:

Approved in United States as Hytrin for:

• Benign prostatic hyperplasia (enlarged prostate)
• Hypertension (high blood pressure)

Approved in United States as Tezruly for:

• Benign prostatic hyperplasia (enlarged prostate)
• Hypertension (high blood pressure)

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials

117

Recruited

537,000+

Published Research Related to This Trial

Terazosin is a selective alpha 1-adrenoceptor blocker that effectively lowers blood pressure and can be taken once daily due to its long half-life, making it convenient for patients with mild-to-moderate hypertension.

It has a significant advantage over prazosin due to its greater water solubility and longer duration of action, and it is safe to use in combination with other antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Terazosin: a new alpha adrenoceptor blocking drug. Achari, R., Laddu, A.[2019]

In a 6-month study comparing terazosin and enalapril, both antihypertensive medications showed similar effectiveness, with about 60% of patients continuing their prescriptions.

The differences in prescribing patterns were influenced more by marketing strategies and physician perceptions than by any significant clinical differences between the two drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing and usage patterns of two antihypertensive agents: a comparison of terazosin and enalapril. Toiber, F., Murthy, VS.[2015]

In a pilot study involving 15 patients with benign prostatic hyperplasia (BPH), terazosin significantly improved both peak and mean urine flow rates, as well as reduced residual urine volume and obstructive symptoms (p < 0.001).

These preliminary results suggest that terazosin is an effective treatment option for alleviating symptoms associated with BPH, supporting its therapeutic value in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of terazosin in the treatment of benign prostatic hyperplasia. A pilot study. Dunzendorfer, U.[2013]

Terazosin is an effective once-daily medication for lowering blood pressure in patients with mild to moderate hypertension, as demonstrated in four out of five randomized controlled trials.

The drug was well tolerated overall, but some patients experienced side effects like dizziness and peripheral edema, which were more common than in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Terazosin: a new alpha 1-blocker for the treatment of hypertension: a review of randomized, controlled clinical trials of once-daily administration as monotherapy. Luther, RR., Glassman, HN., Sperzel, WD., et al.[2013]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545208/

Terazosin - StatPearls - NCBI Bookshelf - NIH Terazosin is a medication used in the management and treatment of benign prostatic hyperplasia and essential hypertension.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11265993/

Effect of low‐dose terazosin on arterial stiffness improvement The 3‐month follow‐up revealed consistent results, suggesting a significantly reduced risk of non‐response to Terazosin in patients with higher ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0149291807001130

Effects of branded versus generic terazosin hydrochloride ... The aim of this study was to compare the efficacy and tolerability of branded versus generic terazosin hydrochloride in adult patients with symptomatic BPH in ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/218139s000lbl.pdf

TEZRULY (terazosin) oral solution - accessdata.fda.gov Limited data show that the peak blood pressure response measured 2 to 3 hours post-dose is greater than about twice the trough (24 hour) response during chronic ...

5. heart.bmj.com heart.bmj.com/content/97/Suppl_3/A246.1

Efficacy of terazosin therapy for mild hypertension patients ... Terazosin therapy appears to be efficacious in relieving LUTS and decreasing blood pressure for mild hypertension patients with LUTS secondary to BPH.

6. mayoclinic.org mayoclinic.org/drugs-supplements/terazosin-oral-route/description/drg-20066315

Terazosin (oral route) - Side effects & dosage Safety and efficacy have not been established. Geriatric. No information is available on the relationship of age to the effects of terazosin ...

7. medlineplus.gov medlineplus.gov/druginfo/meds/a693046.html

Terazosin: MedlinePlus Drug Information Terazosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH), which include difficulty urinating.

8. drugs.com drugs.com/terazosin.html

Terazosin: Uses, Dosage, Side Effects, Warnings Terazosin is used to treat hypertension (high blood pressure) and benign prostatic hyperplasia (enlarged prostate). Learn about side effects ...