RecruitingPhase 2

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

United States280 participantsStarted 2025-10-31

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of written informed consent before any study-specific procedure.
✓. Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.
✓. 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.
✓. Mean BP of ≥ 130/80 mm Hga.
✓. Men and nonpregnant, nonlactating women. Women must be either:
✓. Body mass index of 18 to 35 kg/m2.
✓. Negative prestudy urine drugs of abuse screen (with the exception of tetrahydrocannabinol \[THC\]).
✓. If taking a PDE5 inhibitor for erectile dysfunction, must be willing to pause use during the study period.

Exclusion criteria

What they're measuring

Mean change in systolic blood pressure at 4 weeks

Timeframe: 4 weeks

Trial details

NCT IDNCT07142356

SponsorRetension Pharmaceuticals. Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Medical Information Information

7036242024 info@retensionpharmaceuticals.com

View on ClinicalTrials.gov More Uncontrolled Hypertension trials