Clinical Trials in the USA / NCT07142356
Recruiting
Phase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
NCT07142356 · tracked via the Priya Life Science USA tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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