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Recruiting Phase 2

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

NCT07142356 · tracked via the Priya Life Science USA tracker
Sponsor
Retension Pharmaceuticals. Inc
Phase
Phase 2
Started
2025-10-31
Last updated
2026-10-02

Condition(s) studied

Uncontrolled Hypertension

Investigational drug(s) / intervention(s)

RTN-001Matching placebo control

RTN-001: Oral tablet

Matching placebo control: Oral tablet with similar appearance as the RTN-001.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Mean change in systolic blood pressure (SBP) at 4 weeks — 4 weeks
    The difference in the mean change in pre-dose office-seated peripheral systolic blood pressure in patients with uncontrolled hypertension after 4 weeks of treatment with RTN-001 versus placebo.

Trial sites (34)

FacilityCityRegionStatus
Retension Clinical Site Alexander City Alabama Recruiting
Retension Clinical Site Birmingham Alabama Recruiting
Retension Clinical Site Tucson Arizona Recruiting
Retension Clinical Site San Jose California Recruiting
Retension Clinical Site West Hills California Recruiting
Retension Clinical Site Waterbury Connecticut Recruiting
CRO Call Center Maitland Florida Recruiting
Retension Clinical Site Orlando Florida Recruiting
Retension Clinical Site Port Orange Florida Recruiting
Retension Clinical Site Tampa Florida Recruiting
CRO Call Center Decatur Georgia Recruiting
Retension Clinical Site Lawrenceville Georgia Recruiting
Retension Clinical Site Peachtree Corners Georgia Recruiting
CRO Call Center Indianapolis Indiana Recruiting
CRO Call Center Munster Indiana Recruiting
CRO Call Center New Orleans Louisiana Recruiting
Retension Clincial Site Boston Massachusetts Recruiting
CRO Call Center Methuen Massachusetts Recruiting
CRO Call Center Overland Missouri Recruiting
Retension Clinical Site Las Vegas Nevada Recruiting
Retension Clinical Site Las Vegas Nevada Recruiting
Retension Clinical Site The Bronx New York Recruiting
Retension Clinical Site Asheboro North Carolina Recruiting
Retension Clinical Site Charlotte North Carolina Recruiting
Retension Clinical Site Monroe North Carolina Recruiting
Retension Clinical Site Cincinnati Ohio Recruiting
CRO Call Center Tulsa Oklahoma Not Yet Recruiting
Retension Clinical Site Charleston South Carolina Recruiting
Retension Clinical Site Bellaire Texas Recruiting
Retension Clinical Site Dallas Texas Recruiting
Retension Clincal Site Plano Texas Recruiting
Retension Clinical Site San Antonio Texas Recruiting
Retension Clinical Site Sugar Land Texas Recruiting
Retension Clinical Site Vienna Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07142356 on ClinicalTrials.gov ↗ ← All trials in the USA