Uncontrolled HypertensionPhase 2NCT07142356
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
A Phase 2 study testing RTN-001 in people with Uncontrolled Hypertension, run by Retension Pharmaceuticals. Inc. at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- RTN-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 34 sitesUnited States
- Study dates
- 31 Oct 2025to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United States34 sites, 34 recruiting
- Recruiting
Retension Clinical Site
Alexander City, Alabama, 35010
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Asheboro, North Carolina, 27203
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Bellaire, Texas, 77401
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Birmingham, Alabama, 35222
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clincial Site
Boston, Massachusetts, 02131
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Charleston, South Carolina, 29407
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Charlotte, North Carolina, 28210
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Cincinnati, Ohio, 45245
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Dallas, Texas, 75230
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Decatur, Georgia, 30030
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Indianapolis, Indiana, 46202
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Las Vegas, Nevada, 89109
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- Recruiting
Retension Clinical Site
Las Vegas, Nevada, 89121
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Lawrenceville, Georgia, 30044
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Maitland, Florida, 32751
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Methuen, Massachusetts, 01844
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- Recruiting
Retension Clinical Site
Monroe, North Carolina, 28112
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Munster, Indiana, 46321
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- Recruiting
CRO Call Center
New Orleans, Louisiana, 70115
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- Recruiting
Retension Clinical Site
Orlando, Florida, 32801
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Overland, Missouri, 66209
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- Recruiting
Retension Clinical Site
Peachtree Corners, Georgia, 30092
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- Recruiting
Retension Clincal Site
Plano, Texas, 75024
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- Recruiting
Retension Clinical Site
Port Orange, Florida, 32127
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- Recruiting
Retension Clinical Site
San Antonio, Texas, 78215
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- Recruiting
Retension Clinical Site
San Jose, California, 95128
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- Recruiting
Retension Clinical Site
Sugar Land, Texas, 77478
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- Recruiting
Retension Clinical Site
Tampa, Florida, 33606
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- Recruiting
Retension Clinical Site
The Bronx, New York, 10455
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- Recruiting
Retension Clinical Site
Tucson, Arizona, 85715
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- Not yet recruiting
CRO Call Center
Tulsa, Oklahoma, 74133
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- Recruiting
Retension Clinical Site
Vienna, Virginia, 22182
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- Recruiting
Retension Clinical Site
Waterbury, Connecticut, 06708
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- Recruiting
Retension Clinical Site
West Hills, California, 91307
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About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.
Read the detailed description
This is a Phase 2b, randomized, double-blind, parallel group, multicenter safety and efficacy study evaluating RTN-001 in adult patients (18 to 75 years) with resistant and uncontrolled hypertension (SBP ≥135 mm Hg and a DBP ≥80 mm Hg). The study consists of 3 periods, a Screening Period, a Run-in Period, and a Treatment Period.
At the conclusion of the Run-in Period, approximately 280 eligible patients will enter the 12-week Treatment Period and be randomly assigned to a treatment group (1:1:1:1). An Off-treatment (OT) Follow-up Visit will occur 2 weeks after conclusion of the Treatment Period.
- Conditions
- Uncontrolled Hypertension
- Being tested
- RTN-001, Matching placebo control
- Keywords
- hypertension, uncontrolled hypertension, RTN-001, blood pressure, systolic, diastolic
- Medical subject headings
- Hypertension, Systolic Murmurs, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTN-001Drug
Also called SLx-2101
Oral tablet
Matching placebo controlDrug
Also called Placebo
Oral tablet with similar appearance as the RTN-001.
| Study group | Role | What they receive |
|---|---|---|
| RTN-001 (15 mg) | Experimental | Not described Receives: Drug: RTN-001 |
| RTN-001 (30 mg) | Experimental | Not described Receives: Drug: RTN-001 |
| RTN-001 (45 mg) | Experimental | Not described Receives: Drug: RTN-001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic blood pressure (SBP) at 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.
Measured: 4 weeks
Secondary outcomes (8)
Mean change in pre-dose office-seated SBP at 2, 8, and 12 weeks
Difference in the mean change in pre-dose office-seated SBP in participants with uncontrolled hypertension after 2, 8, and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 2, 8, and 12 weeks
Mean change in pre-dose central SBP at 2, 4, 8, and 12 weeks
Difference in the mean change in pre-dose central SBP in participants with uncontrolled hypertension after 2, 4, 8, and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 2, 4, 8, and 12 weeks
Mean change in daytime ambulatory SBP at 4 and 12 weeks
Difference in the mean change in daytime ambulatory SBP in participants with uncontrolled hypertension after 4 and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 4 and 12 weeks
Mean change in 24-hour ambulatory SBP at 4 and 12 weeks
Difference in the mean change in 24-hour ambulatory SBP in participants with uncontrolled hypertension after 4 and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 4 and 12 weeks
Mean change in pre-dose office-seated DBP
Difference in the mean change in pre-dose office-seated DBP in participants with uncontrolled hypertension after 2, 4, 8, and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 2, 4, 8, and 12 weeks
Mean change in predose central DBP at 2, 4, 8, and 12 weeks
Difference in the mean change in pre-dose central DBP in participants with uncontrolled hypertension after 2, 4, 8, and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 2, 4, 8, and 12 weeks
Mean change in daytime ambulatory and 24-hour mean ambulatory DBP at 4 and 12 weeks
Difference in the mean change in daytime ambulatory and 24-hour mean ambulatory DBP in participants with uncontrolled hypertension after 4 and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 4 and 12 weeks
Mean change in percentage of participants achieving peripheral SBP < 130 mm Hg and/or DBP < 80 mm Hg at t=0 (pre-dose) at 2, 4, 8, and 12 weeks
Difference in the percentage of participants achieving peripheral SBP < 130 mm Hg and/or DBP < 80 mm Hg at t=0 (pre-dose) in participants with uncontrolled hypertension after 2, 4, 8, and 12 weeks of treatment with RTN-001 versus placebo.
Measured: 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start31 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retension Pharmaceuticals. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142356
- Sponsor's protocol ID
- RTN-001-025-012
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided