A Phase 2 interventional study of RTN-001 and Matching placebo control in Uncontrolled Hypertension, sponsored by Retension Pharmaceuticals. Inc.. Recruiting at 44 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Retension Pharmaceuticals. Inc. · Phase 2, Interventional, and Treatment
…and 5 more changes, on the record history on ClinicalTrials.gov ↗
The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 280 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Retension Pharmaceuticals. Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: RTN-001
Drug: RTN-001
Drug: RTN-001
Drug: Matching placebo control
Oral tablet
Also known as: SLx-2101
Oral tablet with similar appearance as the RTN-001.
Also known as: Placebo
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 2, 4, 8, and 12 weeks
Plan to share: Undecided
Started Oct 2025 (actual). Primary completion is estimated for Mar 2027, 17 months after the start.
Of 56 industry-sponsored phase 2 interventional studies under Hypertension, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 22. This study's planned 17 months is above that.
Counting every sponsor, half of 110 studies reached it within 25 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
…and 5 more changes, on the record history on ClinicalTrials.gov ↗
…and 5 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Retension Pharmaceuticals. Inc.