Recruiting
Phase 2

RT-001

Sponsor:

Retension Pharmaceuticals. Inc.

Code:

NCT07142356

Conditions

Uncontrolled Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RTN-001

Matching placebo control

Study Details

Brief 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.

Conditions

Uncontrolled Hypertension

Study ID

NCT07142356

Start date

Oct 31, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RTN-001 (15 mg)

experimental: RTN-001 (30 mg)

experimental: RTN-001 (45 mg)

placebo comparator: Placebo

Interventions

RTN-001

Oral tablet

Matching placebo control

Oral tablet with similar appearance as the RTN-001.

Primary outcome measure

  • Mean change in systolic blood pressure (SBP) at 4 weeks [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Clinical Information

7036242024clinicalinformation@retensionpharmaceuticals.com

Locations

Retension Clinical Site

Recruiting

Alexander City, Alabama, United States, 35010

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Birmingham, Alabama, United States, 35222

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Tucson, Arizona, United States, 85715

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

San Jose, California, United States, 95128

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

West Hills, California, United States, 91307

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Maitland, Florida, United States, 32751

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Orlando, Florida, United States, 32801

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Port Orange, Florida, United States, 32127

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Tampa, Florida, United States, 33606

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Decatur, Georgia, United States, 30030

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Lawrenceville, Georgia, United States, 30044

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Peachtree Corners, Georgia, United States, 30092

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Munster, Indiana, United States, 46321

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

CRO Call Center

participate@worldwide.com

Retension Clincial Site

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Methuen, Massachusetts, United States, 01844

Contacts

CRO Call Center

participate@worldwide.com

CRO Call Center

Recruiting

Overland, Missouri, United States, 66209

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

The Bronx, New York, United States, 10455

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Asheboro, North Carolina, United States, 27203

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Bellaire, Texas, United States, 77401

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Dallas, Texas, United States, 75230

Contacts

CRO Call Center

participate@worldwide.com

Retension Clincal Site

Recruiting

Plano, Texas, United States, 75024

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

San Antonio, Texas, United States, 78215

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

CRO Call Center

participate@worldwide.com

Retension Clinical Site

Recruiting

Vienna, Virginia, United States, 22182

Contacts

CRO Call Center

participate@worldwide.com

More Information

Sponsor

Retension Pharmaceuticals. Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • hypertension
  • uncontrolled hypertension
  • RTN-001
  • blood pressure
  • systolic
  • diastolic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Retension Pharmaceuticals. Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.