Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension

Completed

Phase 3 Results

Results

196 were randomized to receive either cilnidipine or losartan: 98 patients were randomized to each treatment arm. Of the 196 patients, 167 patients completed adequate baseline and final SPECT assessments (83 in the cilnidipine arm and 84 in the losartan arm). Global CBF increased significantly in the cilnidipine arm (9.0 ± 29.6%, P = 0.0071) and the losartan arm (11.4 ± 31.4%, P = 0.0012), and these changes were not different between the two groups (P = 0.607). However, the estimated difference in percentage global CBF change between the two groups was -2.43% (97.5% CI, -13.06% to 8.21%), which crossed the predetermined non-inferiority margin of -8.6%. Ipsilesional hemispheric CBF change, non-impairment of global CBF and BP reduction were similar in the two groups.