A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure

Phase 2

Completed

Conditions: Prehypertension
Hypertension, Stage I

Interventions: Biological: Vehicle
Biological: B244

Registration Number: NCT02998840

Lead Sponsor: AOBiome LLC

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

Detailed Description: This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle application on BP and inflammatory biomarkers.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 132

Inclusion Criteria

Male and female subjects ≥18 years of age
In good general health as determined by a thorough medical history and physical examination, and vital signs
Clinical diagnosis of elevated Blood Pressure defined as:
- Having systolic prehypertension measurements having systolic BP (mmHg) of 120-139 and Diastolic BP (mmHg) of 90
- OR
- Having systolic Stage 1 hypertension measurements having systolic BP (mmHg) of 140-159 and Diastolic BP (mmHg) of 100
Hypertension treatment naïve patients, defined as those patients who have never been treated with antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
Willing to refrain from using any antihypertensive treatments, other than the investigational product, including herbal supplements, systemic use of steroids, chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics, ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and vasodilators.
Ability to comprehend and comply with procedures
Agree to commit to participate in the current protocol
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Exclusion Criteria

Pregnant and/or lactating women
Patients on treatment for Benign Prostatic Hyperplasia (BPH)
Clinically significant history of cardiovascular disease (i. e. PCI, CABG MI (if event occurred 12 months), atrial fibrillation, frequent PAC, cardiac rhythm disorder, syncope, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, unstable angina, TIA, stroke and NYHF category II, II and IV heart failure.
Patients with renal failure, significant kidney or renal disease defined as having creatinine level of mg/dL
Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient's successful participation for the duration of the study
History of migraines and/or anxiety, where patient is unable to refrain from the use of beta blockers
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
The participant has been previously randomized in this study
Subjects with clinical diagnosis of Type I Diabetes
Subjects with arm circumference of 42 cm
Any condition that would prevent the subject from participating in the trial in the opinion of the evaluation physician
The participant has received an investigational product within 30 days prior to randomization
Prior use of any product containing B244 or Nitrosomonas eutropha
Unable to lie flat or sit for 15 minutes
Concurrent participation in other trials

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle 8 pumps applied to face and torso	Vehicle	8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B 244 8 Pumps applied to face and torso	B244	8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
Vehicle 4 pumps applied to the face	Vehicle	4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244 4 pumps applied to the face	B244	4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Baseline-6 weeks	Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups	Baseline-Week 4	Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.

Secondary Outcome Measures

Name	Time	Method
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group	Baseline-Week 4	Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure	Baseline-Week 4	An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.

Trial Locations

Locations (10): Clinical Research Consulting
🇺🇸
Milford, Connecticut, United States
MedPharmics
🇺🇸
Metairie, Louisiana, United States
Research Trials WorldWide
🇺🇸
Humble, Texas, United States
Central Research Associates
🇺🇸
Birmingham, Alabama, United States
AGA Clinical Trials
🇺🇸
Hialeah, Florida, United States
ICCT Research International
🇺🇸
Chicago, Illinois, United States
Elite Clinical Studies
🇺🇸
Phoenix, Arizona, United States
CHEAR Center
🇺🇸
Bronx, New York, United States
Orange County Research Center
🇺🇸
Tustin, California, United States
Alternative Primary Care (Einstein Clinical Research)
🇺🇸
Silver Spring, Maryland, United States