NCT00437645
Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
See it on ClinicalTrials.gov ↗1,183 people
48.1%
51.9%
569 womenmiddle line = equal numbers614 men
- Phase
- PHASE3
- Paid for by
- Novartis Pharmaceuticals
- Finished
- 2007-11
- Health conditions
- Essential Hypertension
- Who could join
- Anyone
- Ages
- 55 Years – no maximum
- Average age
- mean 65.5 Age (years)
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Not reported
Women left out
- No pregnant women
Women who were pregnant could not join.
“Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant”
- No women who could get pregnant
Most women roughly 15–50 years old were turned away.
“Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“…econdary form of hypertension, including but not limited to any of the following: Coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1”
- No diabetes
Women with diabetes were turned away.
“Patients with Type 1 diabetes mellitus”
Study titles and rules are shown in their original English.