Abstract
The efficacy and safety of different doses of a new controlled release formulation of isradipine (isradipine-CR, ICR) were evaluated in patients with mild to moderate (stages 1 and 2) essential hypertension in a placebo-controlled study. Of 402 randomized patients, 384 completed the study (placebo = 77, 5 mg ICR = 76, 10 mg ICR = 76, 15 mg ICR = 78, 20 mg ICR = 77). All doses of ICR decreased the blood pressure and the effect was greater with doses of 10, 15, and 20 mg once daily (P < .001). The most common clinical side effect was mild ankle edema, which was dose dependent, occurring in 35.5% of the patients taking the 20-mg ICR dose. This study showed that ICR is long acting, effective, and well tolerated.
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