CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 132 enrolled
Drug / intervention
B244 +1 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Elevated blood pressure: either systolic 120-139 mmHg with diastolic <90 mmHg (prehypertension) OR systolic 140-159 mmHg with diastolic <100 mmHg (Stage 1 hypertension)
  • ✓Hypertension treatment-naïve: never treated with antihypertensive medications or off treatment for ≥12 weeks
  • ✓Good general health on medical history and physical examination
Key exclusion· 10
  • ✕Pregnant or lactating
  • ✕Significant cardiovascular disease history including prior MI (if within 12 months), PCI, CABG, atrial fibrillation, cardiac rhythm disorder, valve repair/replacement, heart transplant, stroke, TIA, or NYHA Class II, III, or IV heart failure
  • ✕Renal failure or significant kidney disease (creatinine level specified but not completed in criteria)
  • ✕History of migraines and/or anxiety requiring beta-blockers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02998840
NCT02998840Phase 2Completed
CompareCT.gov

A Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure

AOBiome LLC·interventional·Posted Dec 21, 2016·Updated Sep 15, 2022

In Brief

A Phase 2 clinical trial evaluating B244 and Vehicle for Prehypertension and Hypertension, Stage I. Completed, enrolled 132 participants across 10 sites.

Detailed Summary

The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrehypertension, Hypertension, Stage I
CountriesUnited States
CollaboratorsVeristat, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 21, 2016
Enrollment StartNov 1, 2016
Primary CompletionApr 25, 2017
Study CompletionJun 26, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.5 years ago

Interventions

B244biological

odorless suspension

Vehiclebiological

odorless suspension