Phase 2b Randomized Study of Oral RTN-001 for Adults with Uncontrolled Hypertension on Multiple Blood Pressure Medications

What this Trial Is About

Researchers are evaluating RTN-001, a drug, to see if it can reduce high blood pressure in adults with uncontrolled hypertension who are already taking multiple blood pressure medications. This Phase 2b, randomized, double-blind study involves adults aged 18 to 70 years with blood pressure above specified thresholds despite treatment with at least two antihypertensive drugs. The study compares RTN-001 to a placebo to understand its effect on blood pressure and monitor safety. Participants will undergo a screening period up to 14 days to confirm eligibility, followed by a 14-day single-blind run-in period to test compliance and baseline blood pressure measurement. Then, around 280 patients will be randomly assigned to one of four groups to receive daily oral doses of RTN-001 at 15 mg, 30 mg, 45 mg, or placebo for 12 weeks. Blood pressure and laboratory tests will be performed at multiple visits, and ambulatory blood pressure monitoring will occur twice during treatment. After treatment ends, a follow-up phone call will assess any side effects or medication changes. During the study, participants will visit the clinic approximately every two weeks for blood pressure checks, blood sampling, and other assessments. They will keep a diary of symptoms and medications taken. Researchers will measure changes in systolic and diastolic blood pressure using office and ambulatory methods, evaluate drug levels and safety markers, and monitor adverse effects. The total participation includes screening, run-in, treatment, and a follow-up phone call about two weeks after treatment ends.

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension