Study on COgnition and Prognosis in the Elderly (SCOPE)

The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multicentr e, prospective, randomized, double-blind, parallel-group study designed to compare the effects of candesartan cilexetil and placebo in elderly patient s with mild hypertension. The primary objective of the study is to assess t he effect of candesartan cilexetil on major cardiovascular events. The seco ndary objectives of the study are to assess the effect of candesartan cilex etil on cognitive function and on-total mortality, cardiovascular mortality , myocardial infarction, stroke, renal function, hospitalization, quality o f life and health economics. Male and female patients aged between 70 and 8 9 years, with a sitting systolic blood pressure (SBP) of 160-179 mmHg and/o r diastolic blood pressure (DBP) of 90-99 mmHg, and a Mini-Mental State Exa mination (MMSE) score of 24 or above, are eligible for the study. The overa ll target study population is 4000 patients, at least 1000 of whom are also to be assessed for quality of life and health economics data. After an ope n run-in period lasting 1-3 months, during which patients are assessed for eligibility and those who are already on antihypertensive therapy at enrolm ent are switched to hydrochlorothiazide 12.5 mg o.d., patients are randomiz ed to receive either candesartan cilexetil 8 mg once daily (o.d.) or matchi ng placebo o.d. At subsequent study visits, if SEP remains >160 mmHg, or ha s decreased by <10 mmHg since the randomization visit, or DBP is >85 mmHg, study treatment is doubled to candesartan cilexetil 16 mg o.d. or two place bo tablets o.d. Recruitment was completed in January 1999. At that time 496 4 patients had been randomized. All randomized patients will be followed fo r an additional 2 years. If the event rate is lower than anticipated, the f ollow-up will be prolonged.