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

Primary Purpose

Prehypertension, Hypertension, Stage I

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
B244
Vehicle
Sponsored by
AOBiome LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring elevated blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Research Associates
  • Elite Clinical Studies
  • Orange County Research Center
  • Clinical Research Consulting
  • AGA Clinical Trials
  • ICCT Research International
  • MedPharmics
  • Alternative Primary Care (Einstein Clinical Research)
  • CHEAR Center
  • Research Trials WorldWide

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Sham Comparator

Arm Label

B244 4 pumps applied to the face

B 244 8 Pumps applied to face and torso

Vehicle 4 pumps applied to the face

Vehicle 8 pumps applied to face and torso

Arm Description

4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.

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.

4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
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
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

Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
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
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.

Full Information

First Posted
November 22, 2016
Last Updated
August 23, 2022
Sponsor
AOBiome LLC
Collaborators
Veristat, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02998840
Brief Title
A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AOBiome LLC
Collaborators
Veristat, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension, Stage I
Keywords
elevated blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B244 4 pumps applied to the face
Arm Type
Active Comparator
Arm Description
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Arm Title
B 244 8 Pumps applied to face and torso
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vehicle 4 pumps applied to the face
Arm Type
Sham Comparator
Arm Description
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Arm Title
Vehicle 8 pumps applied to face and torso
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
B244
Intervention Description
odorless suspension
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
odorless suspension
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Time Frame
Baseline-6 weeks
Title
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
Description
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.
Time Frame
Baseline-Week 4
Secondary Outcome Measure Information:
Title
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
Description
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.
Time Frame
Baseline-Week 4
Title
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
Description
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.
Time Frame
Baseline-Week 4
Other Pre-specified Outcome Measures:
Title
Difference in Inflammatory Biomarkers Between Active and Vehicle Groups
Description
To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.
Time Frame
Baseline-Week 4
Title
Microbial Content
Description
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Time Frame
Baseline, Day 28, Day 42
Title
Microbial Composition
Description
Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.
Time Frame
Baseline, Day 28, Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Weiss, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Research Consulting
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
ICCT Research International
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
MedPharmics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Alternative Primary Care (Einstein Clinical Research)
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20190
Country
United States
Facility Name
CHEAR Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Research Trials WorldWide
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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