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NCT07142356PHASE2Recruiting

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

Retension Pharmaceuticals. Inc.

Start Date

10/31/2025

Completion Date

6/1/2027

Summary

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

Detailed Description

This is a Phase 2b, randomized, double-blind, parallel group, multicenter safety and efficacy study evaluating RTN-001 in adult patients (18 to 75 years) with resistant and uncontrolled hypertension (SBP ≥135 mm Hg and a DBP ≥80 mm Hg). The study consists of 3 periods, a Screening Period, a Run-in Period, and a Treatment Period. At the conclusion of the Run-in Period, approximately 280 eligible patients will enter the 12-week Treatment Period and be randomly assigned to a treatment group (1:1:1:1). An Off-treatment (OT) Follow-up Visit will occur 2 weeks after conclusion of the Treatment Period.

Eligibility Criteria

Age Range: 18 years to 75 years

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).

Interventions

DRUG

RTN-001

DRUG

Matching placebo control

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Conditions

Uncontrolled Hypertension

Locations

Retension Clinical Site

Alexander City, Alabama 35010

United States

Retension Clinical Site

Birmingham, Alabama 35222

United States

Retension Clinical Site

Tucson, Arizona 85715

United States

Retension Clinical Site

San Jose, California 95128

United States

Retension Clinical Site

West Hills, California 91307

United States

Retension Clinical Site

Waterbury, Connecticut 06708

United States

CRO Call Center

Maitland, Florida 32751

United States

Retension Clinical Site

Orlando, Florida 32801

United States

Retension Clinical Site

Port Orange, Florida 32127

United States

Retension Clinical Site

Tampa, Florida 33606

United States

CRO Call Center

Decatur, Georgia 30030

United States

Retension Clinical Site

Lawrenceville, Georgia 30044

United States

Retension Clinical Site

Peachtree Corners, Georgia 30092

United States

CRO Call Center

Indianapolis, Indiana 46202

United States

CRO Call Center

Munster, Indiana 46321

United States

CRO Call Center

New Orleans, Louisiana 70115

United States

Retension Clincial Site

Boston, Massachusetts 02131

United States

CRO Call Center

Methuen, Massachusetts 01844

United States

CRO Call Center

Overland, Missouri 66209

United States

Retension Clinical Site

Las Vegas, Nevada 89109

United States

Retension Clinical Site

Las Vegas, Nevada 89121

United States

Retension Clinical Site

The Bronx, New York 10455

United States

Retension Clinical Site

Asheboro, North Carolina 27203

United States

Retension Clinical Site

Charlotte, North Carolina 28210

United States

Retension Clinical Site

Monroe, North Carolina 28112

United States

Retension Clinical Site

Cincinnati, Ohio 45245

United States

CRO Call Center

Tulsa, Oklahoma 74133

United States

Retension Clinical Site

Charleston, South Carolina 29407

United States

Retension Clinical Site

Bellaire, Texas 77401

United States

Retension Clinical Site

Dallas, Texas 75230

United States

Retension Clincal Site

Plano, Texas 75024

United States

Retension Clinical Site

San Antonio, Texas 78215

United States

Retension Clinical Site

Sugar Land, Texas 77478

United States

Retension Clinical Site

Vienna, Virginia 22182

United States