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

August 23, 2022 updated by: AOBiome LLC

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting
    • Florida
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60611
        • ICCT Research International
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • MedPharmics
    • Maryland
      • Silver Spring, Maryland, United States, 20190
        • Alternative Primary Care (Einstein Clinical Research)
    • New York
      • Bronx, New York, United States, 10459
        • CHEAR Center
    • Texas
      • Humble, Texas, United States, 77338
        • Research Trials WorldWide

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: B244 4 pumps applied to the face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Biological: B244
odorless suspension
Active Comparator: B 244 8 Pumps applied to face and torso
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.
Biological: B244
odorless suspension
Sham Comparator: Vehicle 4 pumps applied to the face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Biological: Vehicle
odorless suspension
Sham Comparator: Vehicle 8 pumps applied to face and torso
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.
Biological: Vehicle
odorless suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Baseline-6 weeks
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Baseline-6 weeks
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
Time Frame: 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.
Baseline-Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
Time Frame: 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.
Baseline-Week 4
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
Time Frame: 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.
Baseline-Week 4

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in Inflammatory Biomarkers Between Active and Vehicle Groups
Time Frame: Baseline-Week 4
To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.
Baseline-Week 4
Microbial Content
Time Frame: Baseline, Day 28, Day 42
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Baseline, Day 28, Day 42
Microbial Composition
Time Frame: Baseline, Day 28, Day 42
Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.
Baseline, Day 28, Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AOBiome LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Veristat, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Larry Weiss, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVB244-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings