RecruitingUncontrolled Hypertension

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

Eligible age

18–70 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

The goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001

Sponsor: Retension Pharmaceuticals. Inc.

You may qualify if…

✓ 1. Provision of written informed consent before any study-specific procedure.
✓ 2. Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.
✓ 3. Uncontrolled HTN despite being on a stable regimen of ≥ 2 antihypertensive medications in the following drug classes: ACE-inhibitors, ARBs, beta blockers, calcium channel blockers, mineralocorticoid receptor antagonists, or diuretics. A stable regimen is defined as being on the same medications and the same dose for at least 30 days before screening. A combination pill containing 2 separate classes of antihypertensive drugs is considered 2 antihypertensive medications.
✓ 4. Mean BP of ≥ 130/80 mm Hga.
✓ 5. Men and nonpregnant, nonlactating women. Women must be either:
✓ Naturally postmenopausal defined as ≥ 1 year without menses and follicle-stimulating hormone ≥ 40.0 IU/L, or
✓ Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or
✓ Women of childbearing potential must be willing to use 2 acceptable methods of birth control (unless they have agreed to follow the definition of true abstinence). The minimal requirement for adequate contraception should be started the day of Visit T1 (Day 1), continuing during the Treatment Period and for at least 30 days after the last dose of study drug. Acceptable methods of birth control include:

You may not qualify if…

✕ 1. Currently enrolled in a study with an investigational product or any other type of medical research within 30 days before randomization.
✕ 2. Mean seated SBP \> 170 mm Hg and/or DBP \> 110 mm Hg.
✕ 3. Current or planned use of nitrates and/or alpha-blockers or other drugs known to affect BP during the study period (except for those allowed in the protocol; Section 5.9.2) including SGLT2 inhibitors and GLP-1 agonists.
✕ 4. Regular user of PDE5 inhibitors or cannot/is unwilling to refrain from use of PDE5 inhibitors for 7 days before and during their participation in the study.
✕ 5. History of hypotension, fainting spells, or blackouts, including orthostatic hypotension.
✕ 6. Malignant HTN, primary aldosteronism, or secondary HTN.
✕ 7. Active pancreatitis.
✕ 8. A history of drug abuse.