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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the target engagement of Terazosin (TZ) in a single cohort of 6 healthy adult participants. During the study participants will undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and an optional lumbar puncture (LP.)

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.

What data supports the effectiveness of the drug Terazosin?

Terazosin is effective in lowering blood pressure and improving symptoms of benign prostatic hyperplasia (BPH), a condition that affects the prostate gland in men. It has been shown to improve urine flow rates and reduce symptoms in BPH patients, and it is also effective as a once-daily treatment for mild to moderate high blood pressure. ^{1 2 3 4 5}

Is terazosin safe for humans?

Terazosin has been shown to be generally safe in humans, with common side effects including dizziness, headache, and weakness. It has been studied in patients with high blood pressure and urinary issues, and no unknown adverse reactions were observed in these studies. ^{1 3 6 7 8}

How is the drug Terazosin unique compared to other treatments?

Terazosin is unique because it is a selective alpha 1-adrenoceptor blocker with a long duration of action, allowing for once-daily dosing, and it has greater water solubility than similar drugs, which can facilitate intravenous use. ^{1 3 4 8 9}

Research Team

Jordan Schultz, PharmD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Terazosin: a new alpha adrenoceptor blocking drug. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Prescribing and usage patterns of two antihypertensive agents: a comparison of terazosin and enalapril. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical trials with terazosin. General methods. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2013]

6. Japan pubmed.ncbi.nlm.nih.gov

[The efficacy and safety of terazosin and tamsulosin in patients with urinary disturbance accompanying prostatic hypertrophy]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Overall safety of terazosin as an antihypertensive agent. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of terazosin on functional bladder outlet obstruction in women: a pilot study. [2013]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

High-dose terazosin therapy (5mg) in Korean patients with lower urinary tract symptoms with or without concomitant hypertension: a prospective, open-label study. [2022]