RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of modified-release RTN-001 and how well it lowers blood pressure compared with a placebo (a treatment with no active drug). It is for adults ages 18 to 75 whose blood pressure stays high while taking 2 to 5 blood pressure medicines.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 75 at the screening visit.
  • High blood pressure that is not controlled while taking a steady treatment plan of 2 to 5 blood pressure medicines.
  • Average blood pressure of at least 135/80 mm Hg.
  • Body mass index (BMI), a measure based on height and weight, from 18 to 35.

Who can't join

  • Average blood pressure while seated above 175 for the top number or 110 for the bottom number. A history of low blood pressure, fainting, blackouts, or problems with automatic body functions, including blood pressure drops when standing.
  • Use or planned use of nitrates, alpha-blockers, or other listed drugs that affect blood pressure; or drugs or herbs that strongly block the CYP3A4 enzyme. Use of PDE5 inhibitors that you cannot or will not stop for 7 days before and throughout the study.
  • High blood pressure caused by another medical condition, such as certain hormone problems or narrowed kidney arteries; or significant narrowing of the heart's aortic valve.
  • A heart attack or hospital stay for unstable chest pain in the past 3 months; uncontrolled heart rhythm problems with symptoms; or a heart rhythm problem not stable for 3 months. Severe heart failure symptoms (class III–IV) also exclude you. People with pacemakers or implanted defibrillators may qualify if the study doctor finds them stable for 3 months.
  • An uncontrolled underactive thyroid, liver disease, kidney filtering rate below 45, or inflammation of the kidney filters. A history of diabetes, or suspected diabetes with an A1C above 10% or fasting blood sugar above 250 mg/dL at screening.
  • An active infection, major illness, blood or clotting disorder, or active cancer. An unexplained creatine kinase (CK) level above 3 times the normal upper limit before treatment assignment; CK is an enzyme measured in blood.
  • Digestive system conditions or past procedures, including weight-loss surgery, that may affect how your body takes in the study drug.
  • Any history of partial or total vision loss, even if temporary; a crowded optic disc, where nerve fibers are tightly packed at the back of the eye; or retinitis pigmentosa, a rare inherited eye disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (34)

AL

AZ

CA

CT

FL

GA

IN

LA

MA

MO

NC

NV

NY

OH

OK

SC

TX

VA