Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07142356

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

Led by Retension Pharmaceuticals. Inc. · Updated on 2026-04-27

280

Participants Needed

20

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before any study procedure
  • Male or female patients aged 18 to 70 years at screening
  • Uncontrolled hypertension despite being on a stable regimen of at least 2 antihypertensive medications for at least 30 days
  • Mean blood pressure of 130/80 mm Hg or higher
  • Men and nonpregnant, nonlactating women; women must be postmenopausal, surgically sterile, or willing to use two acceptable methods of birth control
  • Body mass index between 18 and 35 kg/m2
  • Negative urine drug screen except for THC
  • Willing to pause use of PDE5 inhibitors for erectile dysfunction during the study period
Not Eligible

You will not qualify if you...

  • Currently enrolled in another investigational study within 30 days before randomization
  • Mean seated systolic blood pressure over 170 mm Hg and/or diastolic blood pressure over 110 mm Hg
  • Use of nitrates, alpha-blockers, or other drugs affecting blood pressure during the study (except allowed ones)
  • Regular use of PDE5 inhibitors or unwillingness to refrain from use 7 days before and during the study
  • History of hypotension, fainting, blackouts, or orthostatic hypotension
  • Malignant hypertension, primary aldosteronism, or secondary hypertension
  • Active pancreatitis
  • History of drug abuse
  • Alcohol abuse exceeding 21 units/week for males or 14 units/week for females
  • Gastrointestinal, liver, or kidney disease that may affect drug metabolism
  • Recent serious cardiovascular events or planned major surgery
  • Uncontrolled hypothyroidism or unstable thyroid conditions
  • Positive hepatitis B or C serology or significant liver enzyme elevations
  • Renal dysfunction with eGFR below 45 mL/min/1.73 m2
  • Gastrointestinal conditions affecting drug absorption
  • Blood disorders or low hemoglobin below 10.0 g/dL
  • Active malignancy requiring recent treatment except certain skin or cervical cancers
  • Unexplained elevated creatine kinase above 3 times normal
  • Recent blood donation, trauma, transfusion, or surgery within 30 days
  • Use of experimental drugs within 30 days
  • Employment or family relationship with study personnel
  • Other conditions deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 20 locations

1

Retension Clinical Site

San Jose, California, United States, 95128

Actively Recruiting

2

Retension Clinical Site

West Hills, California, United States, 91307

Actively Recruiting

3

Retension Clinical Site

Waterbury, Connecticut, United States, 06708

Actively Recruiting

4

Retension Clinical Site

Orlando, Florida, United States, 32801

Actively Recruiting

5

Retension Clinical Site

Port Orange, Florida, United States, 32127

Actively Recruiting

6

Retension Clinical Site

Tampa, Florida, United States, 33606

Actively Recruiting

7

Retension Clinical Site

Lawrenceville, Georgia, United States, 30044

Actively Recruiting

8

Retension Clincial Site

Boston, Massachusetts, United States, 02131

Actively Recruiting

9

Retension Clinical Site

Las Vegas, Nevada, United States, 89109

Actively Recruiting

10

Retension Clinical Site

Las Vegas, Nevada, United States, 89121

Actively Recruiting

11

Retension Clinical Site

Asheboro, North Carolina, United States, 27203

Actively Recruiting

12

Retension Clinical Site

Charlotte, North Carolina, United States, 28210

Actively Recruiting

13

Retension Clinical Site

Monroe, North Carolina, United States, 28112

Actively Recruiting

14

Retension Clinical Site

Cincinnati, Ohio, United States, 45245

Actively Recruiting

15

Retension Clinical Site

Charleston, South Carolina, United States, 29407

Actively Recruiting

16

Rretension clinical site

Bellaire, Texas, United States, 77401

Actively Recruiting

17

Retension Clinical Site

Dallas, Texas, United States, 75230

Actively Recruiting

18

Retension Clincal Site

Plano, Texas, United States, 75024

Actively Recruiting

19

Retension Clinical Site

San Antonio, Texas, United States, 78215

Actively Recruiting

20

Retension Clinical Site

Vienna, Virginia, United States, 22182

Actively Recruiting

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Research Team

M

Medical Information Information

CONTACT

B

Bill CMO, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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