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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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 20 locations
1
Retension Clinical Site
San Jose, California, United States, 95128
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2
Retension Clinical Site
West Hills, California, United States, 91307
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3
Retension Clinical Site
Waterbury, Connecticut, United States, 06708
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4
Retension Clinical Site
Orlando, Florida, United States, 32801
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5
Retension Clinical Site
Port Orange, Florida, United States, 32127
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6
Retension Clinical Site
Tampa, Florida, United States, 33606
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7
Retension Clinical Site
Lawrenceville, Georgia, United States, 30044
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8
Retension Clincial Site
Boston, Massachusetts, United States, 02131
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9
Retension Clinical Site
Las Vegas, Nevada, United States, 89109
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10
Retension Clinical Site
Las Vegas, Nevada, United States, 89121
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11
Retension Clinical Site
Asheboro, North Carolina, United States, 27203
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12
Retension Clinical Site
Charlotte, North Carolina, United States, 28210
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13
Retension Clinical Site
Monroe, North Carolina, United States, 28112
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14
Retension Clinical Site
Cincinnati, Ohio, United States, 45245
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15
Retension Clinical Site
Charleston, South Carolina, United States, 29407
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16
Rretension clinical site
Bellaire, Texas, United States, 77401
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17
Retension Clinical Site
Dallas, Texas, United States, 75230
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18
Retension Clincal Site
Plano, Texas, United States, 75024
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19
Retension Clinical Site
San Antonio, Texas, United States, 78215
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20
Retension Clinical Site
Vienna, Virginia, United States, 22182
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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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