A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
Condition: Prehypertension; Hypertension, Stage I
MeSH terms: Hypertension; Prehypertension
Intervention: B244; Vehicle
Intervention description: odorless suspension; odorless suspension
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: elevated blood pressure

Summary:

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

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