NCT00347360
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
See it on ClinicalTrials.gov ↗654 people
35.5%
64.5%
232 womenmiddle line = equal numbers422 men
- Phase
- PHASE3
- Paid for by
- GlaxoSmithKline
- Finished
- 2008-04
- Health conditions
- Hypertension
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- mean 53.1 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 63.8% · Black / African American 29.7% · Asian 5% · Other 1.1% · American Indian / Alaska Native 0.3% · Native Hawaiian / Pacific Islander 0.2%
Women left out
- No pregnant women
Women who were pregnant could not join.
“…(i.e., no menstrual period for a minimum of 12 months prior to Screening) or surgically sterilized are eligible for the study. If judged appropriate, a postmenopausal woman may be required to have a documented negative urine pregnancy test.”
- No women who could get pregnant
Most women roughly 15–50 years old were turned away.
“Is female of childbearing potential. NOTE: Female subjects who are postmenopausal (i.e., no menstrual period for a minimum of 12 months prior to Screening) or surgically sterilized are eligible for the study. If judged appropriate, a postme…”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“renal disease defined as estimated Glomerular Filtration Rate (eGFR) \<30mL/min per 1.73 m2 hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical ass…”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“uncontrollable or symptomatic arrhythmias unstable angina or angina treated with a beta-blocker sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker) bradycardia (sitting heart ra…”
- No diabetes
Women with diabetes were turned away.
“Subject has DBP =90 mmHg (or for diabetic subjects, DBP =80 mmHg) on two antihypertensive medications.”
- No cancer
Women with current or past cancer were turned away.
“Subject has malignant (accelerated) hypertension, history of malignant hypertension, or secondary forms of hypertension.”
Study titles and rules are shown in their original English.