Retension Pharmaceuticals. Inc.
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 Peri…
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…
Oral tablet
Oral tablet with similar appearance as the RTN-001.