Tests RTN-001 in adults with high blood pressure not controlled by treatment

Trial details

Who runs it

Retension Pharmaceuticals. Inc.

Trial code

NCT07142356

Record updated

4 November 2026

Original description

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

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

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

Inclusion: 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: 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; 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; Any prescription or over-the counter drugs or herbal supplements known to be strong inhibitors of CYP3A4 enzymes; 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.); Liver disease or dysfunction; 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; 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; NHYA class III-IV symptoms of heart failure; Unexplained creatine kinase (CK) >3 × ULN at any time before randomization; History of diabetes or suspected diabetes with glycosylated hemoglobin > 10% or fasting glucose >250 mg/dl at Screening Visit (S1); Mean seated SBP >175 mm Hg and/or DBP >110 mm Hg; Uncontrolled hypothyroidism; Renal dysfunction (<45 mL/min/1.73m²) or glomerulonephritis.

ClinicalTrials.gov NCT07142356