A multicenter clinical trial for evaluation of cilnidipine in patients with mild to moderate essential hypertension

Objective:To evaluate the efficacy and safety of cilnidipine in patients with mild to moderate essential hypertension.Methods:A multicenter,randomized,double blind and parallel control clinical trial recruited 227 patients with mild to moderate essential hypertensive patients,who were ran- domized to one of two treatment groups:cilnidipine capsules (5 mg,n=114) or cilnidipine tablets (5mg,n=113),once daily for 2 weeks.After 2-week washout period,the patients started oral admin- istration of study drugs.The patients with seated DBP≥90 mmHg at the end of 2 weeks were titrated the dose to 10 mg once daily for additional 6 weeks.The patients were monitored on blood pressure,heart rates,physical symptoms and signs as well as incidence of adverse events at the end of washout and 2,4, 6 and 8 weeks after the therapy.Laboratory examinations and electrocardiogram were performed at base- line and the end of the trial.Results:Of 203 patients who completed the trial,101 were in the capsules group and 102 in tablets group.At the end of 8 weeks,the response rate of the cilnidipine capsules and tablets groups was 78.22% vs.80.39% (P＞0.05).At the end of 2,4,6 and 8 weeks,seated systolic blood pressure (SBP) and diastolic blood pressure (DBP) were significantly lowered compared with those at baseline.No significant differences were found in the reduction of blood pressure and the patients' num- ber who needed double dosing at the end of the first 2-week therapy between two groups.The incidence of adverse events experienced by patients between two groups showed no statistical difference.Conclusion: Cilnidipine capsules are effective and safe in patients with mild to moderate essential hypertension.