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The effects of 10 weeks of treatment with isradipine (ISRP), a new dihydropyridine Ca antagonist, was evaluated in a prospective, randomized, double-blind, parallel group, hydrochlorothiazide (HCTZ) controlled study in patients with mild to moderate hypertension. Of 98 patients enrolled, 73 completed the study and were deemed valid for efficacy analyses; 36 in the ISRP group and 37 in the HCTZ group. Monotherapy with ISRP significantly (P less than 0.001) decreased (mean +/- SD) sitting systolic blood pressure (BP) from 146 +/- 11 mm Hg to 128 +/- 11 mm Hg and diastolic BP from 100 +/- 4 mm Hg to 83 +/- 5 mm Hg. Heart rate during the plateau period was not significantly different (76 +/- 11 vs 78 +/- 11 bpm) between the ISRP and HCTZ groups. These reductions in BP were comparable to monotherapy with HCTZ. The mean reduction in diastolic BP with ISRP (17 +/- 6 mm Hg) was significantly (P less than 0.05) greater than that with HCTZ (14 +/- 5 mm Hg). The mean doses for ISRP and HCTZ were 12 mg/day and 60 mg/day, respectively. There was no significant difference in frequency of common side effects (headache, nausea, fatigue, dizziness, palpitations) between the two groups. However, transient or intermittent peripheral edema occurred more frequently in ISRP group. Four patients in ISRP group (two due to edema and two due to palpitations) and two patients in HCTZ group (due to poor BP control) were discontinued from the study. Our results indicate that ISRP in doses of 5 to 10 mg bid is as effective as HCTZ as monotherapy in the treatment of mild to moderate hypertension.