NCT02586155
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
See it on ClinicalTrials.gov ↗2,418 people
25.6%
74.4%
618 womenmiddle line = equal numbers1,800 men
- Phase
- PHASE3
- Paid for by
- Resverlogix Corp
- Finished
- 2021-06-21
- Health conditions
- Diabetes Mellitus, Type 2, Coronary Artery Disease
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- median 62.0 years
- Age 65+
- 34.3%
- Weight (BMI)
- median 29.585 kg/m2
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 87.6% · Not reported 8.4% · American Indian / Alaska Native 2.4% · Asian 1.6% · Native Hawaiian / Pacific Islander 0% · Black / African American 0% · More than one race 0%
Women left out
- No pregnant women
Women who were pregnant could not join.
“Pregnancy”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“…terilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or diaphragm) or remain abstinent from Screening to Follow-up Visit”
- Only women past menopause
Women who could still get pregnant were turned away.
“Female subjects of non-childbearing potential (post-surgical sterilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or di…”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“Evidence of severe renal impairment as determined by either eGFR\<30 mL/min/1.7m2 at Visit 1 or current need for dialysis”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Heart disease which will w/in 90 days of Visit 1 likely need coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement”
- No cancer
Women with current or past cancer were turned away.
“History of malignancy of any organ syst treated/untreated w/in the past 2 yrs whether or not there is evidence of local recurrence/metastases except localized basal skin cell carcinoma”
Study titles and rules are shown in their original English.