A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Retension Pharmaceuticals. Inc.
Summary
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
Description
This is a Phase 2b, randomized, double-blind, parallel group, multicenter study conducted in the United States. Patients who have uncontrolled hypertension (SBP ≥ 130 mm Hg and DBP ≥ 80 mm Hg on ≥ 2 antihypertensive medications) and are aged 18 to 70 years, inclusive, will be eligible for screening. Patients will be stratified by the number of antihypertensive medications they are receiving (2 or ≥ 3), by sex (male, female), and by race (Black, non-Black). The study consists of 3 periods, a Screening Period, a Run-in Period, and a Treatment Period. An Off-treatment (OT) Follow-up Visit will o…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of written informed consent before any study-specific procedure. 2. Male or female patients age 18 to 70 years, inclusive, at the Screening Visit. 3. 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 antihyperte…
Interventions
- DrugRTN-001
A potent and selective PDE5 inhibitor.
- DrugMatching placebo control
The reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.
Locations (20)
- Retension Clinical SiteSan Jose, California
- Retension Clinical SiteWest Hills, California
- Retension Clinical SiteWaterbury, Connecticut
- Retension Clinical SiteOrlando, Florida
- Retension Clinical SitePort Orange, Florida
- Retension Clinical SiteTampa, Florida