Women were less than half of the people tested for almost all of these common medicines.
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NCT00649389

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

See it on ClinicalTrials.gov ↗

2,492 people

1,174 womenmiddle line = equal numbers1,318 men
Phase
PHASE3
Paid for by
Daiichi Sankyo
Finished
2009-12
Health conditions
Hypertension
Who could join
Anyone
Ages
18 Years – 80 Years
Average age
mean 55.1 years
Age 65+
18.9%
Weight (BMI)
mean 937 Participants
Pregnancy recorded
Not reported
Menopause recorded
Not reported
Results shown by sex
Not split by sex
Race
White 66.5% · Black / African American 30.4% · Asian 2% · Not reported 0.6% · American Indian / Alaska Native 0.4% · Native Hawaiian / Pacific Islander 0.2%

Women left out

  • No pregnant women

    Women who were pregnant could not join.

    “Pregnant or lactating females.”
  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “Pregnant or lactating females.”
  • Had to use birth control

    Women who couldn't or didn't want to use birth control were turned away.

    “Will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide”
  • Only women past menopause

    Women who could still get pregnant were turned away.

    “Has been postmenopausal for a least 1 year”
  • No kidney or liver problems

    Women with kidney or liver problems were turned away.

    “History of secondary hypertension including renal disease, pheochromocytoma, or Cushing's syndrome.”
  • No heart disease

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

    “History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina within the past 6 months.”
  • No diabetes

    Women with diabetes were turned away.

    “Uncontrolled Type I or Type II diabetes defined as HbA1c \>9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit. Undocumented subjects must have their HbA1c assessed prior to randomization. Note: Subjects…”
  • No cancer

    Women with current or past cancer were turned away.

    “Subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin.”

Study titles and rules are shown in their original English.