Women were less than half of the people tested for almost all of these common medicines.
PregnancyCommunity forum

NCT00413049

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

See it on ClinicalTrials.gov ↗

696 people

243 womenmiddle line = equal numbers453 men
Phase
PHASE3
Paid for by
Novartis
Finished
2007-11
Health conditions
Hypertension
Who could join
Anyone
Ages
18 Years – 85 Years
Average age
mean 53.8 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.

    “Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/ml).”
  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/ml).”
  • No hormonal birth control

    Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.

    “…dy and for 7 days after study drug discontinuation. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Hormonal contraceptive use was disallowed.”
  • No kidney or liver problems

    Women with kidney or liver problems were turned away.

    “…a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease.”
  • No heart disease

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

    “History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or all types of revascularization.”
  • No diabetes

    Women with diabetes were turned away.

    “All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who were not well controlled based on the investigator's clinical judgment. Patients being treated for diabetes mellitus had to have satisfactory me…”
  • No cancer

    Women with current or past cancer were turned away.

    “Malignant hypertension.”

Study titles and rules are shown in their original English.