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

Prehypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998840
• Other study ID #: AVB244-003
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 26, 2017

Study information

• Verified date: August 2022
• Source: AOBiome LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 26, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Stage I
• Prehypertension

Intervention

Biological:
• B244
odorless suspension
• Vehicle
odorless suspension

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AOBiome LLC	Veristat, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in Inflammatory Biomarkers Between Active and Vehicle Groups	To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.	Baseline-Week 4
Other	Microbial Content	Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.	Baseline, Day 28, Day 42
Other	Microbial Composition	Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.	Baseline, Day 28, Day 42
Primary	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
Primary	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	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.	Baseline-Week 4
Secondary	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.	Baseline-Week 4