Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ¥.
Bibliographical noteFunding Information:
Drs. BH Oh and HY Lee made substantial contributions to the study design, Drs. SH Na, BH Oh, and HY Lee were contributed in the manuscript writing, figure creation. All the authors were equally contributed in the data collection, data interpretation, literature serach, and were involved in all stages of manuscript development. This study was sponsored by LG Life Sciences, Ltd, Seoul, Korea. The sponsor supported the supply of the investigational products, laboratory test, and clinical research coordinator expenses.
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)