Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT07142356
Brief 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
Detailed 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 occur 2 weeks after conclusion of the Treatment Period.
The Screening Period (Visit S1) is up to 14 days in length (Days -28 to -15) and should occur no more than 28 days (± 7 days) before the randomization visit (Visit T1 \[Day 1\]). Patients who successfully complete all screening assessments at Visit S1 move on to the 14-day Run-in Period, which begins with Visit S2 (Day 14). The Run-in Period is single-blind (patients are blinded to the treatment they receive) to assess patient compliance with study drug and the patient's ability to undergo 24-hour ambulatory BP measurement. At Visit S2, patients will have peripheral (seated automated office BP measurement) and central BP measurements and be fitted with the monitor for their baseline 24-hour ambulatory BP measurement (ABPM). Successful completion of the Run-in Period requires \> 80% dosing compliance and confirmation of valid data from baseline 24-hour ambulatory BP monitoring.
At the conclusion of the Run-in Period, approximately 280 eligible patients will enter the 12-week Treatment Period and be randomly assigned (1:1:1:1) to receive 12 weeks of QD treatment with RTN-001 at doses of 15, 30, or 45 mg or matching placebo.
On the morning of Visit T1 (Day 1), before the first administration of study drug, randomized patients will undergo baseline peripheral and central BP measurements and laboratory testing.
Patients will return for study visits at Week 2 (Visit T2 /Day 15), Week 4 (Visit T3/Day 29), Week 8 (Visit T4/Day 57), and Week 12 (Visit T5/Day 85/End of Study).
At each of the last 3 study site visits during the Treatment Period (Visits T3, T4, and T5), patients will undergo peripheral and central BP measurements. At these visits, as well as at Visit T2, patients will undergo blood sampling. Blood samples may be used for safety assessments, determination of drug and metabolite levels, and potential biomarker assessments. Ambulatory BP measurements will be obtained outside of the study site in the temporal proximity of the Week 4 and Week 12 study visit timepoints. A safety review may be conducted after approximately 25% of patients have completed the Week 2 (Visit T2) assessment. If no safety concerns are identified, the sponsor may choose to eliminate this visit from the study schedule.
Patients will receive an OT phone call on Day 99 (Visit OT) approximately 2 weeks after the last dose of RTN-001 or placebo to assess occurrence of adverse events and record changes in concomitant medications.
Study:
NCT07142356
Study Brief:
Protocol Section:
NCT07142356