Rationale, design and patient baseline characteristics of OlmeSartan and calcium antagonists randomized (OSCAR) study: a study comparing the incidence of cardiovascular events between high-dose angiotensin II receptor blocker (ARB) monotherapy and combination therapy of ARB with calcium channel blocker in Japanese elderly high-risk hypertensive patients (ClinicalTrials. gov no. NCT00134160)

Higher doses of angiotensin II receptor blockers (ARBs) are expected to exert more protective effects against cardiovascular diseases. However, the significance of treatment of hypertension with high-dose ARB remains to be defined. The OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study was designed to determine whether high-dose ARB monotherapy is superior to the combination therapy of ARB plus calcium channel blocker (CCB) in the prevention of cardiovascular morbidity/mortality in Japanese elderly high-risk hypertensive patients. The OSCAR study is a multicenter, active-controlled, two-arm parallel group comparison, using the prospective randomized open-blinded end-point method. In the ‘Step 1’ period, elderly hypertensive patients with diabetes or cardiovascular disease received monotherapy with ARB olmesartan medoxomil at a dose of 20 mg day−1. If the target blood pressure control (less than 140/90 mm Hg) was not achieved by ARB monotherapy, the patients were randomized to receive either (1) the increased dose of olmesartan at 40 mg day−1 (high-dose ARB monotherapy) or (2) the addition of a CCB (amlodipine or azelnidipine) to 20 mg day−1 olmesartan (ARB plus CCB combination) in the ‘Step 2’ period. The follow-up duration will be 3 years. The primary end points will be the composite of fatal and non-fatal cardiovascular events, and death from any cause. Recruitment for the OSCAR study (around 1200 patients) was completed by the end of May 2007. The OSCAR study is the first large clinical trial comparing the efficacy of high-dose ARB monotherapy with that of an ARB plus CCB combination therapy in elderly high-risk hypertensive patients.