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A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter 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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug RTN-001 in adults with uncontrolled hypertension to see if it can lower high blood pressure and to assess its safety. This Phase 2b, randomized, double-blind study includes patients aged 18 to 70 years who have uncontrolled hypertension despite taking two or more antihypertensive medications. The study also stratifies patients by medication use, sex, and race to better understand the treatment effects across groups. The trial has three periods: Screening, Run-in, and Treatment. After initial screening, patients enter a 14-day Run-in Period to assess compliance and baseline blood pressure using 24-hour ambulatory monitoring. Eligible patients are then randomly assigned to one of four groups to receive daily oral RTN-001 at doses of 15, 30, or 45 mg, or a matching placebo for 12 weeks. Study visits occur approximately every two weeks, including blood pressure measurements and blood sampling for safety and drug level assessments. Two weeks after treatment ends, a follow-up call checks for adverse events and medication changes. Participants will visit the clinic about every two weeks for checkups and tests, including peripheral and central blood pressure measurements and blood draws. They will keep diaries of symptoms and medications throughout the study. Researchers will measure changes in systolic blood pressure at 4 weeks as the main outcome, along with several secondary blood pressure measures during and after treatment. Safety reviews may occur during the trial, and overall participation lasts from screening through the follow-up call approximately 14 weeks after treatment starts.
CONDITIONS
Brief 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 procedures
- Be male or female aged 18 to 70 years at screening
- Have uncontrolled hypertension despite stable use of 2 or more antihypertensive medications for at least 30 days
- Have a mean blood pressure of at least 130/80 mm Hg
- Women must be nonpregnant, nonlactating, and either postmenopausal, surgically sterile, or willing to use two acceptable birth control methods
- Body mass index between 18 and 35 kg/m2
- Negative urine drug screen (except THC)
- If using PDE5 inhibitors, willing to pause use during the study
You will not qualify if you...
- Enrolled in another investigational study within 30 days before randomization
- Seated systolic blood pressure over 170 mm Hg or diastolic over 110 mm Hg
- Current or planned use of nitrates, alpha-blockers, or other blood pressure affecting drugs not allowed by protocol
- Regular use of PDE5 inhibitors or unwilling to stop their use
- History of hypotension, fainting, or blackouts
- Malignant hypertension, primary aldosteronism, or secondary hypertension
- Active pancreatitis
- History of drug abuse or alcohol abuse above defined limits
- Gastrointestinal, liver, renal, hematologic, or coagulation diseases affecting drug metabolism
- Recent major cardiovascular events or surgeries within 3 months
- Uncontrolled hypothyroidism unless stabilized on therapy
- Active malignancy needing treatment within 5 years except certain skin or cervical cancers
- Abnormal creatine kinase levels without explanation
- Recent blood donation, trauma, transfusion, or surgery within 30 days
- Use of experimental drugs within 30 days before screening
- Employment or family relation to study personnel
- Any condition that increases risk or interferes with study interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants take study drug in a single-blind manner to assess compliance and ability to undergo 24-hour ambulatory blood pressure measurement.
1 visit to begin run-in and ambulatory monitoring
Duration - 12 weeks
Participants receive 12 weeks of daily RTN-001 or placebo with regular blood pressure and blood sampling assessments.
5 visits (Day 1, Week 2, Week 4, Week 8, and Week 12) with ambulatory blood pressure monitoring near Week 4 and Week 12 visits
Duration - Approximately 2 weeks
Participants receive a phone call approximately 2 weeks after treatment ends to assess safety and medication changes.
1 phone call
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
B
Bill CMO, PhD
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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