A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Retension Pharmaceuticals. Inc. · NCT07142356
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 280
- US sites recruiting
- 33
- Study start
- October 31, 2025
- Record last updated
- October 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.
Being studied: RTN-001; Matching placebo control
Conditions: Uncontrolled Hypertension
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Male or female patients age 18 to 75 years, inclusive, at the Screening Visit.
- Uncontrolled HTN despite being on a stable regimen of 2-5 antihypertensive medications.
- Mean BP of ≥135/80 mm Hg.
- Body mass index of 18 to 35 kg/m2.
Exclusion Criteria
- Mean seated SBP >175 mm Hg and/or DBP >110 mm Hg.
- Current or planned use of nitrates and/or alpha-blockers or other drugs known to affect BP during the study period.
- Participants who use PDE5 inhibitors for other indications that cannot or will not refrain from use of PDE5 inhibitors for 7 days before and during their entire period of participation in the study.
- History of hypotension, fainting spells, blackouts or autonomic dysfunction, including orthostatic hypotension.
- Known diagnosis of secondary hypertension (e.g. Cushing's Disease or hyperaldosteronism, renal fibrodysplasia, renal artery stenosis, etc., clinically significant aortic stenosis etc.).
- Recent (within 3 months before the Screening Visit [Visit S1]) myocardial infarction; unstable angina leading to hospitalization; uncontrolled, symptomatic atrial fibrillation, or any cardiac arrhythmia that has not been clinically stable for at least 3 months prior to screening. Participants with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months.
- Uncontrolled hypothyroidism
- Liver disease or dysfunction
- Renal dysfunction (\<45 mL/min/1.73m²) or glomerulonephritis
- Active infection or major illness
- Gastrointestinal conditions or procedures (including weight loss surgery [eg, Lap-Band or gastric bypass]) that may affect drug absorption.
- Hematologic or coagulation disorders
- Active malignancy
- Unexplained creatine kinase (CK) >3 × ULN at any time before randomization
- A known history of temporary or permanent partial or total vision loss
- A known history of "crowded" optic disc.
- A known history of retinitis pigmentosa, a rare genetic eye disease.
- Any prescription or over-the counter drugs or herbal supplements known to be strong inhibitors of CYP3A4 enzymes
- NHYA class III-IV symptoms of heart failure.
- History of diabetes or suspected diabetes with glycosylated hemoglobin > 10% or fasting glucose >250 mg/dl at Screening Visit (S1).
Recruiting US locations
Retension Clinical Site
Alexander City, AL 35010
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Birmingham, AL 35222
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Tucson, AZ 85715
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
San Jose, CA 95128
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
West Hills, CA 91307
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Waterbury, CT 06708
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Maitland, FL 32751
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Orlando, FL 32801
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Port Orange, FL 32127
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Tampa, FL 33606
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Decatur, GA 30030
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Lawrenceville, GA 30044
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Peachtree Corners, GA 30092
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Indianapolis, IN 46202
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Munster, IN 46321
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
New Orleans, LA 70115
Site contact: CRO Call Center · participate@worldwide.com
Retension Clincial Site
Boston, MA 02131
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Methuen, MA 01844
Site contact: CRO Call Center · participate@worldwide.com
CRO Call Center
Overland, MO 66209
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Las Vegas, NV 89109
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Las Vegas, NV 89121
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
The Bronx, NY 10455
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Asheboro, NC 27203
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Charlotte, NC 28210
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Monroe, NC 28112
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Cincinnati, OH 45245
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Charleston, SC 29407
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Bellaire, TX 77401
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Dallas, TX 75230
Site contact: CRO Call Center · participate@worldwide.com
Retension Clincal Site
Plano, TX 75024
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
San Antonio, TX 78215
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Sugar Land, TX 77478
Site contact: CRO Call Center · participate@worldwide.com
Retension Clinical Site
Vienna, VA 22182
Site contact: CRO Call Center · participate@worldwide.com
Study contacts (from the official record)
- Clinical Information · 7036242024 · clinicalinformation@retensionpharmaceuticals.com
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