Study on Cognition and Prognosis in the Elderly "SCOPE"

Completed

Phase 3 Results

Trial Description

To evaluate the prophylactic effect of candesartan cilexetil on major vascular events in elderly patients with mild hypertension.

Interventions

  • Candesartan cilexetil (Atacand®)Drug
    Intervention Desc: AT1 receptor antagonist (antihypertensive)
  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials

Trial Design

Multicenter, prospective, randomized, double-blind, parallel-group study

Patient Involvement

After a 1-3 month run-in period, during which patients were assessed for eligibility and those who were already on antihypertensive therapy were switched to hydrochlorothiazide 12.5 mg/day, patients were randomized to receive either candesartan cilexetil 8 mg/day or placebo once/day . At subsequent study visits, if their SBP was >160 mmHg, had decreased by <10 mmHg since the randomization visit, or if their DBP was > 85 mmHg, study treatment was doubled to candesartan cilexetil 16 mg/day or two placebo tablets once/day. All patients were followed up for 2 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke
Secondary Extent of cognitive function or dementia, measured by the Mini-Mental State Exam (MMSE), total mortality, renal function, hospitalizations, quality of life

Sponsors

AstraZeneca