Uncontrolled Hypertension study: RTN-001
Official title A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
ClinicalTrials.gov ID: NCT07142356
What this study is testing
What is RTN-001?
RTN-001 is an investigational oral tablet being studied as a potential treatment for uncontrolled hypertension.
Also referred to as SLx-2101.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if RTN-001 is safe and works for people whose blood pressure stays high even when they take medicine.
- Who it's for
- Adults who have uncontrolled hypertension.
- What's involved
- Participants will receive either RTN-001 or a placebo and will have regular check‑ups and blood pressure tests.
- Time commitment
- The study lasts several weeks and requires multiple clinic visits for monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Recent (within 3 months before the Screening Visit [Visit S1]) myocardial infarction; unstable angina leading to hospitalization
See the full eligibility 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.
- 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 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Tucson, Arizona, United States
- Pasadena, California, United States
- San Diego, California, United States
- San Jose, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Waterbury, Connecticut, United States
- Boca Raton, Florida, United States
- Jacksonville, Florida, United States
- Leesburg, Florida, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- Lawrenceville, Georgia, United States
- Peachtree Corners, Georgia, United States
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Alexander City, Alabama, United States; Birmingham, Alabama, United States; Glendale, Arizona, United States; Tucson, Arizona, United States; Pasadena, California, United States; San Diego, California, United States and 35 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.