A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
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
Interventions
RTN-001
Matching placebo control
Conditions
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