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
1 other identifier
interventional
280
1 country
20
Brief Summary
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. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2025
CompletedFirst Posted
Study publicly available on registry
August 26, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 27, 2026
April 1, 2026
11 months
August 19, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in systolic blood pressure at 4 weeks
The difference in the mean change in pre-dose office-seated systolic blood pressure in patients with uncontrolled hypertension after 4 weeks of treatment with RTN-001 versus placebo.
4 weeks
Secondary Outcomes (9)
Mean change in daytime ambulatory SBP at 4 weeks
4 weeks
Mean change in daytime ambulatory SBP at 8 and 12 weeks
8 and 12 weeks
Mean change in pre-dose central SBP at 4 and 12 weeks
4 and 12 weeks
Mean change in daytime ambulatory SBP at 12 weeks
12 weeks
Mean change in 24-hour ambulatory SBP at 4 and 12 weeks
4 and 12 weeks
- +4 more secondary outcomes
Study Arms (2)
RTN-001
EXPERIMENTALRTN-001 will be administered orally. RTN-001 tablets will be provided in one dose strength (15 mg). Each patient will take 3 tablets daily of RTN-001, placebo, or both depending on assigned treatment group.
Matching Placebo
PLACEBO COMPARATORThe reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.
Interventions
The reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.
Eligibility Criteria
You may qualify 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 blockers, calcium channel blockers, mineralocorticoid receptor antagonists, or diuretics. A stable regimen is defined as being on the same medications and the same dose for at least 30 days before screening. A combination pill containing 2 separate classes of antihypertensive drugs is considered 2 antihypertensive medications.
- 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 follow the definition of true abstinence). The minimal requirement for adequate contraception should be started the day of Visit T1 (Day 1), continuing during the Treatment Period and for at least 30 days after the last dose of study drug. Acceptable methods of birth control include:
- 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, and withdrawal are not acceptable methods of contraception.
- Body mass index of 18 to 35 kg/m2.
- Negative prestudy urine drugs of abuse screen (with the exception of tetrahydrocannabinol \[THC\]).
- +1 more criteria
You may not qualify 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 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 started or dose changed within 3 months of screening); coronary artery bypass graft; percutaneous coronary intervention; carotid surgery or stenting; cerebrovascular accident; transient ischemic attack; endovascular procedure or surgical intervention for peripheral vascular disease; or plans to undergo a major surgical or interventional procedure (eg, percutaneous coronary intervention, coronary artery bypass graft, carotid or peripheral revascularization). Patients 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, 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 before randomization are allowed.
- 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 obtained, and if consistent with Gilbert's syndrome or if the patient has a history of Gilbert's syndrome, the patient may be enrolled in the study.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Retension Clinical Site
San Jose, California, 95128, United States
Retension Clinical Site
West Hills, California, 91307, United States
Retension Clinical Site
Waterbury, Connecticut, 06708, United States
Retension Clinical Site
Orlando, Florida, 32801, United States
Retension Clinical Site
Port Orange, Florida, 32127, United States
Retension Clinical Site
Tampa, Florida, 33606, United States
Retension Clinical Site
Lawrenceville, Georgia, 30044, United States
Retension Clincial Site
Boston, Massachusetts, 02131, United States
Retension Clinical Site
Las Vegas, Nevada, 89109, United States
Retension Clinical Site
Las Vegas, Nevada, 89121, United States
Retension Clinical Site
Asheboro, North Carolina, 27203, United States
Retension Clinical Site
Charlotte, North Carolina, 28210, United States
Retension Clinical Site
Monroe, North Carolina, 28112, United States
Retension Clinical Site
Cincinnati, Ohio, 45245, United States
Retension Clinical Site
Charleston, South Carolina, 29407, United States
Rretension clinical site
Bellaire, Texas, 77401, United States
Retension Clinical Site
Dallas, Texas, 75230, United States
Retension Clincal Site
Plano, Texas, 75024, United States
Retension Clinical Site
San Antonio, Texas, 78215, United States
Retension Clinical Site
Vienna, Virginia, 22182, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William CMO, PhD
CMO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2025
First Posted
August 26, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.
- Access Criteria
- Requires submission and approval of intended use and a data sharing agreement.
Requests for clinical trial data, including language stating its intended use, should be directed to info@retensionpharmaceuticals.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Retension reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.