NCT00546754

BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)

789 people

47.8%

52.2%

377 womenmiddle line = equal numbers412 men

Phase: PHASE3
Paid for by: Organon and Co
Finished: 2009-05-01
Health conditions: Hypertension
Who could join: Anyone
Ages: 18 Years – 75 Years
Average age: mean 58.5 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 87.5% · Asian 8% · Black / African American 2.7% · Other 1.3% · Not reported 0.4% · Hispanic / Latina 0.3%

Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“…n-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy \[either 2 barrier methods or a barrier method plus a hormonal method\]; or (2) abstain from heterosexual activity throughout…”
Only women past menopause
Women who could still get pregnant were turned away.
“Surgically sterilized female”
No kidney or liver problems
Women with kidney or liver problems were turned away.
“Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine \> 130 Umol/L Or Creatinine Clearance \< 45 Ml/Min, Aspartat…”
No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Patient with symptomatic heart failure (classes 3 and 4)”
No cancer
Women with current or past cancer were turned away.
“Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)”

Study titles and rules are shown in their original English.