Clinical trial NCT02998840: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prehypertension
Hypertension, Stage I
Keywords: elevated blood pressure
Lead sponsor: AOBiome LLC
Sponsor class: INDUSTRY
Collaborators: name: Veristat, Inc.
First posted: 2016-12-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Baseline-6 weeks
measure: Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
timeFrame: Baseline-Week 4
Secondary outcomes:
measure: Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
timeFrame: Baseline-Week 4
measure: Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
timeFrame: Baseline-Week 4
Other outcomes:
measure: Difference in Inflammatory Biomarkers Between Active and Vehicle Groups
timeFrame: Baseline-Week 4
measure: Microbial Content
timeFrame: Baseline, Day 28, Day 42
measure: Microbial Composition
timeFrame: Baseline, Day 28, Day 42
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Chicago
country: United States
facility: ICCT Research International
state: Illinois
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Silver Spring
country: United States
facility: Alternative Primary Care (Einstein Clinical Research)
state: Maryland
city: Bronx
country: United States
facility: CHEAR Center
state: New York
city: Humble
country: United States
facility: Research Trials WorldWide
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: Larry Weiss, MD
role: STUDY_DIRECTOR
References: