Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

Women left out

• Only women past menopause

  Women who could still get pregnant were turned away.

  “Female patients had to be post-menopausal for at least one year.”

• No kidney or liver problems

  Women with kidney or liver problems were turned away.

  “Significant hepatic disease, as demonstrated by any one of the following: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than two times the upper limit of normal at Visit 1, a history of hepatic encephalop…”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “Significant history of coronary artery disease (CAD) such as any history of myocardial infarction (MI), angina pectoris, and all types of revascularization procedures.”

• No diabetes

  Women with diabetes were turned away.

  “All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who, in the opinion of the investigator, were not well controlled. Patients who needed oral anti-diabetic medication to adequately control their Typ…”

• No cancer

  Women with current or past cancer were turned away.

  “Known moderate or malignant retinopathy. Moderate was defined as retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as signs of moderate retinopathy plus swelling of the…”

Study titles and rules are shown in their original English.