Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCZ696; Olmesartan; LCZ696 matching placebo; Olmesartan matching placebo; amlodipine; hydrochlorothiazide
Intervention description: 200 mg tablet; 20 mg and 40 mg capsules; LCZ696 Matching Placebo tablet; Olmesartan matching placebo capsule; amlodipine 2.5 mg or 5 mg tablets; hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 454.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity

Summary:

      The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central
      Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial
      stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened
      pulse pressure (PP).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male and female patients ≥ 60 years of age.

          2. Patients with essential hypertension, untreated or currently taking antihypertensive
             therapy.

          3. Untreated patients must have an office msSBP ≥150 mmHg and <180 mmHg at Visit 101 and
             Visit 201 if they are newly diagnosed or have not been treated with antihypertensive
             drugs for the 4 weeks prior to Visit 1.

          4. Treated patients must have an office msSBP ≥140 mmHg and <180 mmHg at Visit 102 (or
             Visit 103) and msSBP ≥150 mmHg and <180 mmHg at Visit 201 if they have been treated
             with antihypertensive drugs for the 4 weeks prior to Visit 1.

          5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined
             as msSBP- msDBP.

          6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201
             (randomization) and the visit immediately prior to Visit 201.

        Key Exclusion Criteria:

          1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg
             and/or msSBP ≥ 180 mmHg)

          2. History of angioedema, drug-related or otherwise.

          3. History or evidence of a secondary form of hypertension, including but not limited to
             any of the following: renal parenchymal hypertension, renovascular hypertension
             (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease,
             and drug-induced hypertension.

          4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any
             history of stroke.

          5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary
             intervention (PCI) during the 12 months prior to Visit 1.

          6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1,
             or active atrial fibrillation or atrial flutter on the ECG at screening.