This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
AOBiome LLC
ClinicalTrials.gov Identifier:
NCT02998840
First received: November 22, 2016
Last updated: June 27, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension.

Condition Intervention Phase
Prehypertension Hypertension, Stage I Biological: B244 Biological: Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Further study details as provided by AOBiome LLC:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Baseline-6 weeks ]
  • Difference in mean in clinic systolic BP between the active and vehicle groups [ Time Frame: Baseline-Week 4 ]

Secondary Outcome Measures:
  • Difference in mean in clinic diastolic BP between the active and vehicle group [ Time Frame: Baseline-Week 4 ]
  • Difference in mean ambulatory systolic and diastolic daytime blood pressure [ Time Frame: Baseline-Week 4 ]

Other Outcome Measures:
  • Difference in inflammatory biomarkers between active and vehicle groups [ Time Frame: Baseline-Week 4 ]
  • Microbial content [ Time Frame: Baseline, Day 28, Day 42 ]
  • Microbial composition [ Time Frame: Baseline, Day 28, Day 42 ]

Enrollment: 132
Actual Study Start Date: November 2016
Study Completion Date: June 26, 2017
Primary Completion Date: April 25, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02998840

Locations
United States, Alabama
Central Research Associates
Birmingham, Alabama, United States, 35205
United States, Arizona
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
United States, California
Orange County Research Center
Tustin, California, United States, 92780
United States, Connecticut
Clinical Research Consulting
Milford, Connecticut, United States, 06460
United States, Florida
AGA Clinical Trials
Hialeah, Florida, United States, 33012
United States, Illinois
ICCT Research International
Chicago, Illinois, United States, 60611
United States, Louisiana
MedPharmics
Metairie, Louisiana, United States, 70006
United States, Maryland
Alternative Primary Care (Einstein Clinical Research)
Silver Spring, Maryland, United States, 20190
United States, New York
CHEAR Center
The Bronx, New York, United States, 10459
United States, Texas
Research Trials WorldWide
Humble, Texas, United States, 77338
Sponsors and Collaborators
AOBiome LLC
Veristat, Inc.
Investigators
Study Director: Larry Weiss, MD Chief Medical Officer
  More Information

Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT02998840     History of Changes
Other Study ID Numbers: AVB244-003
Study First Received: November 22, 2016
Last Updated: June 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AOBiome LLC:
elevated blood pressure

Additional relevant MeSH terms:
Prehypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 27, 2017