Dilated ureters were also found in the group with valsartan alone (exposure 12 times the clinical dose of 160 mg valsartan). Only modest signs of maternal toxicity (moderate reduction in body weight) were observed in this study. The level of effect not observed for developmental effects was observed at 3 (valsartan) and 4 (amlodipine) times the clinical exposure (based on the AUC).