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

NCT02998840 | Completed Phase 2 Results DMC

• 1 other identifier: AVB244-003
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Prehypertension; Hypertension, Stage I

Keywords

elevated blood pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline-6 weeks

• 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.

  Baseline-Week 4

Secondary Outcomes (2)

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

  Baseline-Week 4

• Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure

  Baseline-Week 4

Other Outcomes (3)

• Difference in Inflammatory Biomarkers Between Active and Vehicle Groups

  Baseline-Week 4

• Microbial Content

  Baseline, Day 28, Day 42

• Microbial Composition

  Baseline, Day 28, Day 42

Study Arms (4)

B244 4 pumps applied to the face

ACTIVE COMPARATOR

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

Biological: B244

B 244 8 Pumps applied to face and torso

ACTIVE COMPARATOR

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

Vehicle 4 pumps applied to the face

SHAM COMPARATOR

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

Biological: Vehicle

Vehicle 8 pumps applied to face and torso

SHAM COMPARATOR

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

Interventions

B244 BIOLOGICAL

odorless suspension

B 244 8 Pumps applied to face and torso; B244 4 pumps applied to the face

Vehicle BIOLOGICAL

odorless suspension

Vehicle 4 pumps applied to the face; Vehicle 8 pumps applied to face and torso

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AOBiome LLC: lead
• Veristat, Inc.: collaborator

Study Sites (10)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

ICCT Research International

Chicago, Illinois, 60611, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

Alternative Primary Care (Einstein Clinical Research)

Silver Spring, Maryland, 20190, United States

Location

CHEAR Center

The Bronx, New York, 10459, United States

Location

Research Trials WorldWide

Humble, Texas, 77338, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Larry Weiss, MD

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2016
• Primary Completion: April 25, 2017
• Study Completion: June 26, 2017
• Last Updated: September 15, 2022
• Results First Posted: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)