A clinical trial comparing the efficacy and safety of Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension

AIM:To assess the comparative efficacy and safety of the Cilnidipine capsules versus Cilnidipine tablets in patients with mild and moderate primary hypertension. METHODS:240 patients were enrolled from 3 Chinese study centers for a randomized,double-blind,parallel-group,active-controlled,8-week clinical trial. Patients were randomly assigned to receive daily dose of Cilnidipine capsules or Cilnidipine tablets 5 after two weeks wash out periods.The efficacy and safety were assessed. RESULTS:The study demonstrated similar reductions at week 8 in both DBP and SBP for both groups. For the primary efficacy analysis of sitting diastolic pressure,there was a mean reduction from baseline of 11.5 mm Hg and 11.3 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups,respectively (P=0.82). The mean reduction from baseline in sitting systolic presure was 14.1 mm Hg and 16.1 mm Hg for the Cilnidipine capsules and Cilnidipine tablets groups,respectively (P=0.50). At the end of the treatment peroid,the total effective rate of Cilnidipine capsules and Cilnidipine tablets groups was 77.2% and 77.9% respectively (P=0.90). For the safety/tolerance,there were 22 and 20 incidences of adverse events regarded relatively with cilnidipine capsules and tables respectively.Most of them were palpitation and dizziness.No statistical difference existed between the two groups with respect to adverse events. Both the two treatment groups were associated with a significantly decrease of heart rate (P=0.0009,P=0.0043). CONCLUSION:Cilnidipine capsules are an effective and well-tolerated antihypertensive for patients with mild to moderate hypertension.