CompletedPhase 2

Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

United States200 participantsStarted 2021-07-01

Plain-language summary

A randomized, double-blind, placebo-controlled, dose-ranging, Phase II study to evaluate the safety, efficacy, and tolerability of MLS-101 in Subjects With Uncontrolled Hypertension

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
✓. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
✓. Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
✓. Background antihypertensive treatment of ≥ 2 drugs
✓. Serum cortisol ≥ 18 mcg/dL

Exclusion criteria

✕. Topical corticoids
✕. Sympathomimetic decongestants
✕. Theophylline
✕. Phosphodiesterase type 5 inhibitors
✕. NSAIDs
✕. Intramuscular steroids
✕. Estrogen
✕. Cytochromes

What they're measuring

Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo

Timeframe: 8 Weeks

Trial details

NCT IDNCT05001945

SponsorMineralys Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-07

Results submitted2023-10-10

View on ClinicalTrials.gov More Hypertension, Renal trials