Modified-release RTN-001 for adults with uncontrolled high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2b trial gives daily modified-release RTN-001 or matching placebo for a 12-week treatment period to adults with uncontrolled hypertension on ≥2 antihypertensive drugs. The protocol includes a screening visit, a 14-day single-blind run-in to confirm dosing compliance and valid 24-hour ambulatory blood pressure monitoring (ABPM), then randomization with stratification by number of medications, sex, and race. Participants attend clinic visits about every two weeks for clinic and central BP measurements, safety tests, and diary reviews, with an off-treatment follow-up two weeks after the treatment period. Primary endpoints include change in ambulatory systolic and diastolic blood pressure and safety/tolerability measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Where it's running

• Retension Clinical Site
  Alexander City, Alabama, United States Recruiting
• Retension Clinical Site
  Birmingham, Alabama, United States Recruiting
• Retension Clinical Site
  Birmingham, Alabama, United States Recruiting
• Retension Clinical Site
  Glendale, Arizona, United States Recruiting
• Retension Clinical Site
  Tucson, Arizona, United States Recruiting
• Retension Clinical Site
  Pasadena, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Information
• Email: clinicalinformation@retensionpharmaceuticals.com
• Phone: 7036242024

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Adaptive program to reduce food insecurity for people with uncontrolled high blood pressure

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• Renal pelvic denervation for adults with uncontrolled high blood pressure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.