Women were less than half of the people tested for almost all of these common medicines.
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NCT00094302

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

See it on ClinicalTrials.gov ↗

3,445 people

1,775 womenmiddle line = equal numbers1,670 men
Phase
PHASE3
Paid for by
Carelon Research
Finished
2013-06
Health conditions
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
Who could join
Anyone
Ages
50 Years – no maximum
Average age
median 68.7 years
Age 65+
62.2%
Weight (BMI)
Not reported
Pregnancy recorded
Not reported
Menopause recorded
Not reported
Results shown by sex
Not split by sex
Race
White 88.9% · Black / African American 8.7% · Not reported 1.5% · Asian 0.6% · American Indian / Alaska Native 0.3% · More than one race 0.1% · Native Hawaiian / Pacific Islander 0%

Women left out

  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “…hild-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation”
  • Had to use birth control

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

    “…hild-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation”
  • No kidney or liver problems

    Women with kidney or liver problems were turned away.

    “Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/…”
  • No heart disease

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

    “Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial”

Study titles and rules are shown in their original English.