Clinical trial NCT01523067 (phase 1, status: completed)
Conditions: essential hypertension
ICD codes: I10, O10.02, O10.03, O10.011, O10.012, O10.013, O10.019
Drugs: vasomera (pb1046), 0.9% sodium chloride
SMILES: [Na+].[Cl-]
Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to sign a written informed consent and follow all study related
             procedures.

          -  Males or females age 18 - 70 years of age inclusive.

          -  Male and female subjects of childbearing potential must be willing and able to
             practice effective contraception during the study, and be willing and able to continue
             contraception for 1 month after their last dose of study drug.

          -  Diagnosis of essential hypertension and: Has a systolic blood pressure between 140-169
             mmHg (between 130-169 mmHg if subject has type 2 diabetes mellitus (T2DM)) or
             diastolic blood pressure 90-109 mmHg (between 85 - 109 if subject has T2DM) who is not
             currently on antihypertensive therapy.

          -  or- Has been taking up to two antihypertensive agents to control blood pressure and
             who in the opinion of the investigator could be safely withdrawn from antihypertensive
             therapy.

          -  BMI ≥ 20 but ≤ 40 kg/m2

          -  The difference (highest to lowest mean values) in mean seated systolic blood pressure
             (triplicate measurements at 1-2 minute interval) measured on three separate occasions
             between Day -4 and Day 0 (pre-dose) is within 14 mmHg and diastolic is within 8 mmHg.

          -  Judged by the Investigator to be in generally stable health (except for hypertension)
             defined as absence of clinically significant laboratory abnormalities, vital signs,
             ECG findings or clinically significant underlying disease that would put the subject
             at risk for participation in the study, or would interfere with interpretation of the
             study results (i.e., secondary hypertension).

          -  Receiving stable doses of protocol permitted concomitant medications for 1 month prior
             to study drug administration with no anticipated dose adjustments during the study
             period.

        Exclusion Criteria:

          -  Screening (triplicate sitting reading 1-2 minutes apart) BP > 169 mmHg (systolic) or >
             109 mmHg (diastolic).

          -  Systolic blood pressure < 130 mmHg or > 169 mmHg and diastolic blood pressure < 85
             mmHg or > 109 mmHg at randomization (Day -1) or prior to the first dose of study drug
             (Day 0)

          -  Unstable/underlying cardiovascular disease defined as in protocol.

          -  Uncontrolled type 2 diabetes mellitus defined as hemoglobin A1c > 9.0%

          -  Clinically significant renal and/or hepatic dysfunction at Screening or at baseline
             (Day -4) as defined in protocol.

          -  Use of non-steroidal anti-inflammatory drugs (excluding prophylactic use of low dose
             aspirin such as 81 - 162 mg) within 2 weeks prior to administration of study drug or
             anticipated use during the study period.

          -  Pregnant or lactating females.

          -  Known latex allergy (Ambulatory Blood Pressure Monitor [ABPM] unit contains latex in
             bladder and tubing).

          -  Known history of or active drug or alcohol abuse within the 12 months prior to
             Screening and/or positive drug screen or detection of alcohol at Screening or at
             baseline (Day -4).

          -  Positive for Human Immunodeficiency Virus (HIV) antibodies, hepatitis B surface
             antigen (HBsAg) or hepatitis C virus (HCV) antibodies.

          -  Participation in any other study and have received any other investigational drug or
             device within 30 days prior to the Screening visit or are taking part in a non-drug
             study which in the opinion of the Investigator would interfere with the outcome of the
             study.

          -  Major surgery, donated or lost > or = 1 unit of blood (approximately 500 mL) within 1
             month prior to randomization (Day -1) or display evidence of volume depletion (i.e.,
             postural hypotension) not otherwise explained by the subject's antihypertensive
             medication regimen.

          -  Other medical or psychiatric condition which in the opinion of the Investigator would
             place the subject at increased risk, would preclude obtaining voluntary consent, or
             would interfere with the interpretation of the results of the study.