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This open-label trial of isradipine was carried out in 3422 outpatients by 893 general practitioners to assess the efficacy, safety, and tolerability of isradipine as monotherapy in mild-to-moderate hypertension. Patients received 2.5 mg isradipine twice daily as monotherapy for 6 weeks following a placebo wash-out period of 1 week. After 6 weeks of active treatment, diastolic blood pressure was significantly reduced from 106 +/- 7.7 to 89.4 +/- 8.0 mm Hg (P < .001). Systolic blood pressure also decreased significantly, from 166.8 +/- 19.6 to 141.8 +/- 15.7 mm Hg (P < .001). Blood pressure was normalized in 75.68% of the patients. A total of 629 patients (19%) reported adverse events, 79 (2.3%) of whom withdrew from the study for this reason. The most common side-effects were headache (8.7%), palpitations/tachycardia (3.8%), vertigo (2.89%) and flushing (1.00%). In conclusion, 2.5 mg isradipine twice daily is a safe, effective, and well tolerated form of monotherapy in the treatment of hypertension in general practice in a developing country (Pakistan).