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 44 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
- 44 sitesUnited States
- Study dates
- 31 Oct 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
United States44 sites, 44 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, 35205
CRO Call Center
- Recruiting
Retension Clinical Site
Birmingham, Alabama, 35222
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Bloomfield Hills, Michigan, 48304
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Boca Raton, Florida, 33434
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
Retension Clinical Site
Glendale, Arizona, 85304
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Indianapolis, Indiana, 46202
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Jacksonville, Florida, 32216
- Recruiting
Retension Clinical Site
Las Vegas, Nevada, 89109
CRO Call Center, participate@worldwide.com
- 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
Retension Clinical Site
Leesburg, Florida, 34748
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Maitland, Florida, 32751
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Methuen, Massachusetts, 01844
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Monroe, North Carolina, 28112
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Munster, Indiana, 46321
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
New Orleans, Louisiana, 70115
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
North Charleston, South Carolina, 29406
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Orlando, Florida, 32801
CRO Call Center, participate@worldwide.com
- Recruiting
CRO Call Center
Overland, Missouri, 66209
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Pasadena, California, 91105
CRO Call Center, participate@worldwide.com
- Recruiting
Retension Clinical Site
Peachtree Corners, Georgia, 30092
CRO Call Center, participate@worldwide.com
- 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 Diego, California, 92109
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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
CRO Call Center, participate@worldwide.com
- Not yet recruiting
CRO Call Center
Tulsa, Oklahoma, 74133
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- Recruiting
Retension Clinical Site
Ventura, California, 93003
CRO Call Center, participate@worldwide.com
- 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
CRO Call Center, participate@worldwide.com
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
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT07142356
- Acronym / sponsor ID
- RTN-001-025-012
- Conditions
- Uncontrolled Hypertension
- Keywords
- hypertension, uncontrolled hypertension, RTN-001, blood pressure, systolic, diastolic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Retension Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RTN-001 (15 mg) | Experimental | Drug: RTN-001 |
| RTN-001 (30 mg) | Experimental | Drug: RTN-001 |
| RTN-001 (45 mg) | Experimental | Drug: RTN-001 |
| Placebo | Placebo comparator | Drug: Matching placebo control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTN-001Also: SLx-2101Oral tablet | Drug | RTN-001 (15 mg), RTN-001 (30 mg), RTN-001 (45 mg) |
| Matching placebo controlAlso: PlaceboOral tablet with similar appearance as the RTN-001. | Drug | Placebo |
Primary outcome
Mean change in systolic blood pressure (SBP) at 4 weeks
Time frame: 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.
8 secondary outcomes
Mean change in pre-dose office-seated SBP at 2, 8, and 12 weeks
Time frame: 2, 8, and 12 weeks
Mean change in pre-dose central SBP at 2, 4, 8, and 12 weeks
Time frame: 2, 4, 8, and 12 weeks
Mean change in daytime ambulatory SBP at 4 and 12 weeks
Time frame: 4 and 12 weeks
Mean change in 24-hour ambulatory SBP at 4 and 12 weeks
Time frame: 4 and 12 weeks
Mean change in pre-dose office-seated DBP
Time frame: 2, 4, 8, and 12 weeks
Mean change in predose central DBP at 2, 4, 8, and 12 weeks
Time frame: 2, 4, 8, and 12 weeks
Mean change in daytime ambulatory and 24-hour mean ambulatory DBP at 4 and 12 weeks
Time frame: 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
Time frame: 2, 4, 8, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Company web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RTN-001 in people with Uncontrolled Hypertension, run by Retension Pharmaceuticals. Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Information (7036242024, clinicalinformation@retensionpharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in systolic blood pressure (SBP) at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.