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

AOBiome

Status and phase: Completed; Phase 2

Conditions: Hypertension, Stage I; Prehypertension

Treatments: Biological: B244; Biological: Vehicle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02998840

AVB244-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 4 patient groups

B244 4 pumps applied to the face

Active Comparator group

Description:

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

Treatment:

Biological: B244

B 244 8 Pumps applied to face and torso

Active Comparator group

Description:

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.

Treatment:

Biological: B244

Vehicle 4 pumps applied to the face

Sham Comparator group

Description:

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

Treatment:

Biological: Vehicle

Vehicle 8 pumps applied to face and torso

Sham Comparator group

Description:

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.

Treatment:

Biological: Vehicle