Among those patients involved in double-blind, randomized, controlled studies of CLARITIN Tablets, approximately 1000 patients (age 12 and older), were enrolled in studies of chronic idiopathic urticaria. In placebo-controlled clinical trials, CLARITIN Tablets 10 mg once daily were superior to placebo in the management of chronic idiopathic urticaria, as demonstrated by reduction of associated itching, erythema, and hives. In these studies, the incidence of somnolence seen with CLARITIN Tablets was similar to that seen with placebo.

In a study in which CLARITIN Tablets were administered to adults at four times the clinical dose for 90 days, no clini-cally significant increase in the QT_c was seen on ECGs.

In a single-rising dose study in which doses up to 160 mg (16 times the clinical dose) were studied, loratadine did not cause any clinically significant changes on the QT_c interval in the ECGs.

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