A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
ConditionUncontrolled Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRetension Pharmaceuticals. Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RTN-001
- Matching placebo control
Treatment groups
280 Participants
are divided into 2 treatment groupsLocations
22Arizona
Retension Clinical Site85715, Tucson United States
California
Retension Clinical Site95128, San Jose United States
Retension Clinical Site91307, West Hills United States
Connecticut
Retension Clinical Site06708, Waterbury United States
Sponsors and collaborators
Retension Pharmaceuticals. Inc.
Lead sponsor
Source ClinicalTrials.gov