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New treatment option for Uncontrolled Hypertension
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 medicine, 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 goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001.
- 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 70
You may be able to join if
- Provision of written informed consent before any study-specific procedure.
- Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.
- Uncontrolled HTN despite being on a stable regimen of ≥ 2 antihypertensive medications in the following drug classes: ACE-inhibitors, ARBs, beta...
- Mean BP of ≥ 130/80 mm Hga.
- Men and nonpregnant, nonlactating women. Women must be either:
You likely can't join if
- Currently enrolled in a study with an investigational product or any other type of medical research within 30 days before randomization.
- Mean seated SBP \> 170 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 (except for those allowed in the...
- Regular user of PDE5 inhibitors or cannot/is unwilling to refrain from use of PDE5 inhibitors for 7 days before and during their participation in the...
- History of hypotension, fainting spells, or blackouts, including orthostatic hypotension.
- Malignant HTN, primary aldosteronism, or secondary HTN.
See the full eligibility criteria
Who can join
- Provision of written informed consent before any study-specific procedure.
- Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.
- Uncontrolled HTN despite being on a stable regimen of ≥ 2 antihypertensive medications in the following drug classes: ACE-inhibitors, ARBs, beta blockers, calcium channel blockers, mineralocorticoid receptor...
- Mean BP of ≥ 130/80 mm Hga.
- Men and nonpregnant, nonlactating women. Women must be either:
- Naturally postmenopausal defined as ≥ 1 year without menses and follicle-stimulating hormone ≥ 40.0 IU/L, or
- Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or Women of childbearing potential must be willing to use 2 acceptable methods of birth control (unless they have agreed to...
- Oral, implantable, injectable, or topical birth control medications. Note: Oral birth control medication must be started ≥ 30 days before the first dose of treatment in the Placebo Run-in.
- Placement of an intrauterine device with or without hormones.
- Barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly.
- Vasectomized male partner who is the sole partner for this patient.
- True abstinence when this is the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of a trial...
- Body mass index of 18 to 35 kg/m2.
- Negative prestudy urine drugs of abuse screen (with the exception of tetrahydrocannabinol [THC]).
- If taking a PDE5 inhibitor for erectile dysfunction, must be willing to pause use during the study period. Only patients with uncontrolled HTN on ≥ 2 accepted classes of antihypertensive drugs who continue to satisfy...
What rules you out
- Currently enrolled in a study with an investigational product or any other type of medical research within 30 days before randomization.
- Mean seated SBP \> 170 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 (except for those allowed in the protocol; Section 5.9.2) including SGLT2 inhibitors and GLP-1 agonists.
- Regular user of PDE5 inhibitors or cannot/is unwilling to refrain from use of PDE5 inhibitors for 7 days before and during their participation in the study.
- History of hypotension, fainting spells, or blackouts, including orthostatic hypotension.
- Malignant HTN, primary aldosteronism, or secondary HTN.
- Active pancreatitis.
- A history of drug abuse.
- Abuses alcohol defined as average weekly intake greater than 21 units for males or 14 units for females. One unit is equivalent to a 12 oz beer, 1 measure of spirits, or 1 glass of wine.
- History or presence of gastrointestinal, hepatic, or renal disease or other conditions that would be known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Recent (within 3 months before the Screening Visit [Visit S1]) myocardial infarction; unstable angina leading to hospitalization; uncontrolled, symptomatic cardiac arrhythmia (or medication for an arrhythmia that was...
- Uncontrolled hypothyroidism, including thyroid-stimulating hormone \> 1.5 × the upper limit of normal (ULN) at the Screening Visit (Visit S1); patients stabilized on thyroid replacement therapy for at least 6 weeks...
- Liver disease or dysfunction, including:
- Positive serology for hepatitis B surface antigen and/or hepatitis C antibodies at the Screening Visit (Visit S1), or
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥ 2 × ULN, and/or total bilirubin (TB) ≥ 2 × ULN at the Screening Visit (Visit S1). If TB ≥ 1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be...
- Renal dysfunction or glomerulonephritis, including estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula \< 45 mL/min/1.73 m2 at the Screening Visit (Visit...
- Gastrointestinal conditions or procedures (including weight loss surgery [eg, Lap-Band or gastric bypass] that may affect drug absorption.
- Hematologic or coagulation disorders or a hemoglobin level \< 10.0 g/dL at the Screening Visit (Visit S1).
- Active malignancy, including a malignancy requiring surgery, chemotherapy, and/or radiation in the 5 years before Screening. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are...
- Unexplained creatine kinase (CK) \> 3 × ULN at any time before randomization, which is not associated with recent trauma or physically strenuous activity. Patients with an explained CK elevation must have a single...
- Blood donation, participation in multiple blood draws, clinical study, major trauma, blood transfusion, or surgery with or without blood loss within 30 days before randomization.
- Use of any experimental or investigational drug(s) within 30 days before Screening.
- An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-investigator, or any Sponsor personnel
- Is considered to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of study outcomes by the Investigator, after reviewing...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- San Jose, California, United States
- West Hills, California, United States
- Waterbury, Connecticut, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Tampa, Florida, United States
- Lawrenceville, Georgia, United States
- Peachtree Corners, Georgia, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- Asheboro, North Carolina, United States
- Charlotte, North Carolina, United States
- Monroe, North Carolina, United States
- Cincinnati, Ohio, United States
- Charleston, South Carolina, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
- Plano, Texas, United States
- San Antonio, Texas, United States
+ 1 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 - 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; San Jose, California, United States; West Hills, California, United States; Waterbury, Connecticut, United States; Orlando, Florida, United States; Port Orange, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.