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
- Retension Clinical Site · Alexander City, AL 35010CRO Call Center · Study contact · participate@worldwide.comMore trials in Alexander City
- Retension Clinical Site · Birmingham, AL 35222CRO Call Center · Study contact · participate@worldwide.comMore trials in Birmingham
AZ
- Retension Clinical Site · Tucson, AZ 85715CRO Call Center · Study contact · participate@worldwide.comMore trials in Tucson
CA
- Retension Clinical Site · San Jose, CA 95128CRO Call Center · Study contact · participate@worldwide.comMore trials in San Jose
- Retension Clinical Site · West Hills, CA 91307CRO Call Center · Study contact · participate@worldwide.comMore trials in West Hills
CT
- Retension Clinical Site · Waterbury, CT 06708CRO Call Center · Study contact · participate@worldwide.comMore trials in Waterbury
FL
- CRO Call Center · Maitland, FL 32751CRO Call Center · Study contact · participate@worldwide.comMore trials in Maitland
- Retension Clinical Site · Orlando, FL 32801CRO Call Center · Study contact · participate@worldwide.comMore trials in Orlando
- Retension Clinical Site · Port Orange, FL 32127CRO Call Center · Study contact · participate@worldwide.comMore trials in Port Orange
- Retension Clinical Site · Tampa, FL 33606CRO Call Center · Study contact · participate@worldwide.comMore trials in Tampa
GA
- CRO Call Center · Decatur, GA 30030CRO Call Center · Study contact · participate@worldwide.comMore trials in Decatur
- Retension Clinical Site · Lawrenceville, GA 30044CRO Call Center · Study contact · participate@worldwide.comMore trials in Lawrenceville
- Retension Clinical Site · Peachtree Corners, GA 30092CRO Call Center · Study contact · participate@worldwide.comMore trials in Peachtree Corners
IN
- CRO Call Center · Indianapolis, IN 46202CRO Call Center · Study contact · participate@worldwide.comMore trials in Indianapolis
- CRO Call Center · Munster, IN 46321CRO Call Center · Study contact · participate@worldwide.comMore trials in Munster
LA
- CRO Call Center · New Orleans, LA 70115CRO Call Center · Study contact · participate@worldwide.comMore trials in New Orleans
MA
- Retension Clincial Site · Boston, MA 02131CRO Call Center · Study contact · participate@worldwide.comMore trials in Boston
- CRO Call Center · Methuen, MA 01844CRO Call Center · Study contact · participate@worldwide.comMore trials in Methuen
MO
- CRO Call Center · Overland, MO 66209CRO Call Center · Study contact · participate@worldwide.comMore trials in Overland
NC
- Retension Clinical Site · Asheboro, NC 27203CRO Call Center · Study contact · participate@worldwide.comMore trials in Asheboro
- Retension Clinical Site · Charlotte, NC 28210CRO Call Center · Study contact · participate@worldwide.comMore trials in Charlotte
- Retension Clinical Site · Monroe, NC 28112CRO Call Center · Study contact · participate@worldwide.comMore trials in Monroe
NV
- Retension Clinical Site · Las Vegas, NV 89109CRO Call Center · Study contact · participate@worldwide.comMore trials in Las Vegas
- Retension Clinical Site · Las Vegas, NV 89121CRO Call Center · Study contact · participate@worldwide.comMore trials in Las Vegas
NY
- Retension Clinical Site · The Bronx, NY 10455CRO Call Center · Study contact · participate@worldwide.comMore trials in The Bronx
OH
- Retension Clinical Site · Cincinnati, OH 45245CRO Call Center · Study contact · participate@worldwide.comMore trials in Cincinnati
OK
- CRO Call Center · Tulsa, OK 74133CRO Call Center · Study contact · participate@worldwide.comMore trials in Tulsa
SC
- Retension Clinical Site · Charleston, SC 29407CRO Call Center · Study contact · participate@worldwide.comMore trials in Charleston
TX
- Retension Clinical Site · Bellaire, TX 77401CRO Call Center · Study contact · participate@worldwide.comMore trials in Bellaire
- Retension Clinical Site · Dallas, TX 75230CRO Call Center · Study contact · participate@worldwide.comMore trials in Dallas
- Retension Clincal Site · Plano, TX 75024CRO Call Center · Study contact · participate@worldwide.comMore trials in Plano
- Retension Clinical Site · San Antonio, TX 78215CRO Call Center · Study contact · participate@worldwide.comMore trials in San Antonio
- Retension Clinical Site · Sugar Land, TX 77478CRO Call Center · Study contact · participate@worldwide.comMore trials in Sugar Land
VA
- Retension Clinical Site · Vienna, VA 22182CRO Call Center · Study contact · participate@worldwide.comMore trials in Vienna