RecruitingPhase 2NCT07142356

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

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


Sponsor

Retension Pharmaceuticals. Inc.

Enrollment

280 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication called RTN-001 to see if it can lower blood pressure in people whose high blood pressure is not well controlled even when taking two or more blood pressure medications. The drug is taken as a modified-release pill and may work through a different pathway than existing medications. **You may be eligible if...** - You are between 18 and 70 years old - You have high blood pressure that remains uncontrolled (130/80 mmHg or above) despite taking at least 2 blood pressure medications - You have been on the same blood pressure medications and doses for at least 30 days - You are not pregnant or breastfeeding **You may NOT be eligible if...** - Your blood pressure is extremely high (over 170 systolic or 110 diastolic) - You have a history of fainting, severe low blood pressure, or blackouts - You have secondary hypertension (blood pressure caused by another condition like a hormone problem) - You have heart disease, kidney disease (low kidney function), or active liver disease - You have had a heart attack, stroke, or major heart procedure within the past 3 months - You regularly use nitrates, alpha-blockers, SGLT2 inhibitors, or GLP-1 agonists - You use PDE5 inhibitors (e.g., Viagra) and cannot stop during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRTN-001

A potent and selective PDE5 inhibitor.

DRUGMatching placebo control

The reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.


Locations(20)

Retension Clinical Site

San Jose, California, United States

Retension Clinical Site

West Hills, California, United States

Retension Clinical Site

Waterbury, Connecticut, United States

Retension Clinical Site

Orlando, Florida, United States

Retension Clinical Site

Port Orange, Florida, United States

Retension Clinical Site

Tampa, Florida, United States

Retension Clinical Site

Lawrenceville, Georgia, United States

Retension Clincial Site

Boston, Massachusetts, United States

Retension Clinical Site

Las Vegas, Nevada, United States

Retension Clinical Site

Las Vegas, Nevada, United States

Retension Clinical Site

Asheboro, North Carolina, United States

Retension Clinical Site

Charlotte, North Carolina, United States

Retension Clinical Site

Monroe, North Carolina, United States

Retension Clinical Site

Cincinnati, Ohio, United States

Retension Clinical Site

Charleston, South Carolina, United States

Rretension clinical site

Bellaire, Texas, United States

Retension Clinical Site

Dallas, Texas, United States

Retension Clincal Site

Plano, Texas, United States

Retension Clinical Site

San Antonio, Texas, United States

Retension Clinical Site

Vienna, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07142356


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