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

NCT00923091

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension

See it on ClinicalTrials.gov ↗

2,689 people

1,443 womenmiddle line = equal numbers1,246 men
Phase
PHASE3
Paid for by
Daiichi Sankyo
Finished
2011-03
Health conditions
Essential Hypertension
Who could join
Anyone
Ages
18 Years – no maximum
Average age
mean 56.5 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
White 99.9% · Asian 0.1% · Black / African American 0%

Women left out

  • No pregnant women

    Women who were pregnant could not join.

    “Female subjects of childbearing potential who are pregnant or lactating.”
  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “Female subjects of childbearing potential who are pregnant or lactating.”
  • No women who could get pregnant

    Most women roughly 15–50 years old were turned away.

    “Female subjects of childbearing potential who are pregnant or lactating.”
  • No kidney or liver problems

    Women with kidney or liver problems were turned away.

    “Subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, or Cushing's syndrome.”
  • No heart disease

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

    “Subjects having a history of the following within the last six months: myocardial infarction (MI), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke),…”
  • No diabetes

    Women with diabetes were turned away.

    “Subjects with uncontrolled Type 1 or Type 2 diabetes defined as HbA1c \> 9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit, or must have their HbA1c assessed prior to randomisation. Note: subjects with…”
  • No mental health conditions

    Women with depression, bipolar disorder or other mental health conditions were turned away.

    “…ts, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematologic or, neurologic, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic subjects.”
  • No cancer

    Women with current or past cancer were turned away.

    “Subjects with a history of a wasting disease (e.g. cancer), autoimmune diseases, connective tissue diseases, major allergies or angioneurotic oedema.”

Study titles and rules are shown in their original English.