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

Conditions

• Uncontrolled Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• RTN-001 — DRUG
  A potent and selective PDE5 inhibitor.
• Matching placebo control — DRUG
  The reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.

Study Details

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

Key Dates

Start date

Oct 31, 2025

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

280 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: RTN-001
  RTN-001 will be administered orally. RTN-001 tablets will be provided in one dose strength (15 mg). Each patient will take 3 tablets daily of RTN-001, placebo, or both depending on assigned treatment group.
• Placebo Comparator: Matching Placebo
  The reference/comparator product is a matching placebo tablet with similar appearance and weight as the RTN-001 oral tablet.

Primary Outcome Measure

Mean change in systolic blood pressure at 4 weeks [ Time Frame: 4 weeks ]

Central Contacts

• Medical Information Information
  7036242024
  [email protected]
• Bill CMO, PhD
  609-651-3773
  [email protected]

Locations (20)

Find similar trials in San Jose, CA

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