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
Age18-75
SponsorRetension Pharmaceuticals. Inc.

About this trial

The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 their entire period of participation in the study.

History of hypotension, fainting spells, blackouts or autonomic dysfunction, including orthostatic hypotension.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RTN-001

    Drug

    Oral tablet

  • Matching placebo control

    Drug

    Oral tablet with similar appearance as the RTN-001.

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: RTN-001 (15 mg)Experimental treatment 1 intervention
Group B: RTN-001 (30 mg)Experimental treatment 1 intervention
Group C: RTN-001 (45 mg)Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in systolic blood pressure (SBP) at 4 weeks

The difference in the mean change in pre-dose office-seated peripheral 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 pre-dose office-seated SBP at 2, 8, and 12 weeks

Difference in the mean change in pre-dose office-seated SBP in participants with uncontrolled hypertension after 2, 8, and 12 weeks of treatment with RTN-001 versus placebo.

Time frame
2, 8, and 12 weeks
2

Mean change in pre-dose central SBP at 2, 4, 8, and 12 weeks

Difference in the mean change in pre-dose central SBP in participants with uncontrolled hypertension after 2, 4, 8, and 12 weeks of treatment with RTN-001 versus placebo.

Time frame
2, 4, 8, and 12 weeks
3

Mean change in daytime ambulatory SBP at 4 and 12 weeks

Difference in the mean change in daytime ambulatory SBP in participants 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 24-hour ambulatory SBP at 4 and 12 weeks

Difference in the mean change in 24-hour ambulatory SBP in participants with uncontrolled hypertension after 4 and 12 weeks of treatment with RTN-001 versus placebo.

Time frame
4 and 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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