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

RecruitingPhase 2

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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).

About the study

The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.

What is being tested

Sponsor: Retension Pharmaceuticals. Inc. · Participants: 280 · Started: Oct 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07142356

Locations in the U.S.

AlabamaRetension Clinical Site, Alexander City
Retension Clinical Site, Birmingham
Retension Clinical Site, Birmingham
ArizonaRetension Clinical Site, Glendale
Retension Clinical Site, Tucson
CaliforniaRetension Clinical Site, Pasadena
Retension Clinical Site, San Diego
Retension Clinical Site, San Jose
Retension Clinical Site, Ventura
Retension Clinical Site, West Hills
ConnecticutRetension Clinical Site, Waterbury
FloridaRetension Clinical Site, Boca Raton
Retension Clinical Site, Jacksonville
Retension Clinical Site, Leesburg
Retension Clinical Site, Maitland
Retension Clinical Site, Orlando
Retension Clinical Site, Port Orange
Retension Clinical Site, Tampa
GeorgiaCRO Call Center, Decatur
Retension Clinical Site, Lawrenceville
Retension Clinical Site, Peachtree Corners
IndianaCRO Call Center, Indianapolis
CRO Call Center, Munster
LouisianaCRO Call Center, New Orleans
MassachusettsRetension Clincial Site, Boston
CRO Call Center, Methuen
MichiganRetension Clinical Site, Bloomfield Hills
MissouriCRO Call Center, Overland
NevadaRetension Clinical Site, Las Vegas
Retension Clinical Site, Las Vegas
New YorkRetension Clinical Site, The Bronx
North CarolinaRetension Clinical Site, Asheboro
Retension Clinical Site, Charlotte
Retension Clinical Site, Monroe
OhioRetension Clinical Site, Cincinnati
OklahomaCRO Call Center, Tulsa (Not yet recruiting)
South CarolinaRetension Clinical Site, Charleston
Retension Clinical Site, North Charleston
TexasRetension Clinical Site, Bellaire
Retension Clinical Site, Dallas
Retension Clincal Site, Plano
Retension Clinical Site, San Antonio
Retension Clinical Site, Sugar Land
VirginiaRetension Clinical Site, Vienna

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.