Health TrialsbyHealthPanel

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

ConditionUncontrolled Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRetension Pharmaceuticals. Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of written informed consent before any study-specific procedure.

Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.

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 antihypertensive drugs is considered 2 antihypertensive medications.

Mean BP of ≥ 130/80 mm Hga.

Disqualifiers

Currently enrolled in a study with an investigational product or any other type of medical research within 30 days before randomization.

Mean seated SBP > 170 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 (except for those allowed in the protocol; Section 5.9.2) including SGLT2 inhibitors and GLP-1 agonists.

Regular user of PDE5 inhibitors or cannot/is unwilling to refrain from use of PDE5 inhibitors for 7 days before and during their participation in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: RTN-001Experimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in systolic blood pressure at 4 weeks

The difference in the mean change in pre-dose office-seated systolic blood pressure in patients with uncontrolled hypertension after 4 weeks of treatment with RTN-001 versus placebo.

Time frame
4 weeks

Secondary outcomes

1

Mean change in daytime ambulatory SBP at 4 weeks

Difference in mean change in daytime ambulatory SBP in patients with uncontrolled hypertension after 4 weeks of treatment with RTN-001 versus placebo.

Time frame
4 weeks
2

Mean change in daytime ambulatory SBP at 8 and 12 weeks

Difference in the mean change in predose office-seated SBP in patients with uncontrolled hypertension after 8 and 12 weeks of treatment with RTN-001 versus placebo.

Time frame
8 and 12 weeks
3

Mean change in pre-dose central SBP at 4 and 12 weeks

Difference in the mean change in predose central SBP in patients with uncontrolled hypertension after 4 and 12 weeks of treatment with RTN-001 versus placebo.

Time frame
4 and 12 weeks
4

Mean change in daytime ambulatory SBP at 12 weeks

Difference in the mean change in daytime ambulatory SBP in patients with uncontrolled hypertension after 12 weeks of treatment with RTN-001 versus placebo.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Retension Pharmaceuticals. Inc.

Lead sponsor

Source ClinicalTrials.gov
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