Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients
Condition: Patients, Resistant Hypertension
MeSH terms: Hypertension
Intervention: LHW090; Placebo
Intervention description: Capsule - oral dose; Capsule - oral dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: resistant hypertension

Summary:

      The purpose of the present study was to determine whether LHW090 displays the clinical safety
      and efficacy profile to support further development in patients with resistant hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients, age 40 to 85 years inclusive.

          -  • Patients with uncontrolled hypertension (here defined as having a mean daytime
             systolic BP ≥ 135 mmHg by ABPM at screening) despite treatment with a stable (at least
             1 month) regimen that includes an optimal dose of an ARB plus a diuretic plus at least
             one additional class of anti-hypertensive medication.

        For the purposes of this trial, optimal doses of anti-hypertensive medications are defined
        as:

          -  the highest dose listed in the clinical practice guideline from the American Society
             for Hypertension and the International Society for Hypertension or

          -  the highest allowable prescribed dose per the manufacturer's label or

          -  the highest dose tolerated by an individual patient or

          -  the highest dose appropriate for an individual patient in the judgment of the
             Investigator

          -  Subjects must weigh at least 45 kg to participate in the study and must have a body
             mass index (BMI) within the range of 18-38 kg/m^2.

        Exclusion Criteria:

          -  Patients with an estimated GFR <60 ml/min/1.73m^2.

          -  Use of angiotensin converting enzyme inhibitors (ACE-inhibitors). Note: Patients who
             discontinue their ACE-inhibitor and substitute with an angiotensin receptor blocker
             may be eligible to be re-screened provided their anti-hypertensive regimen has been
             stable for at least 1 month. Any substitutions or changes to a patient's
             anti-hypertensive regimen should be done under the guidance of the patient's treating
             physician.

          -  Severe hypertension as defined by systolic blood pressure ≥180 mmHg or diastolic blood
             pressure ≥110 mmHg at screening.

          -  A history of secondary hypertension of any etiology including but not limited to
             unilateral or bilateral renal artery stenosis, polycystic kidney disease, coarctation
             of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, and
             drug-induced hypertension.

          -  Known current significant left ventricular outflow obstruction, such as obstructive
             hypertrophic cardiomyopathy or significant severe valvular disease on prior or current
             echocardiogram).

          -  A history of known moderate or malignant retinopathy defined as moderate (retinal
             signs of hemorrhage), microaneurysms, cotton-wool spots, hard exudates, or a
             combination thereof) or malignant (signs of moderate retinopathy plus swelling of the
             optic disk). Patients with a stable ophthalmologic history in the past 6 months are
             eligible.

          -  To facilitate ABPM assessment, an upper arm circumference greater than 42 cm.

          -  History within the previous 6 months of myocardial infarction, coronary artery bypass
             graft (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy,
             stroke, or transient ischemic attack (TIA).

        Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
        after conception and until the termination of gestation, confirmed by a positive hCG
        laboratory test.

        • Women of child-bearing potential