Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

Sang Hoon Na, Hae Young Lee, Sang Hong Baek, Hui Kyung Jeon, Jin Ho Kang, Yoon Nyun Kim, Chang Gyu Park, Jae Kean Ryu, Moo Yong Rhee, Moo Hyun Kim, Taek Jong Hong, Dong Ju Choi, Seong Wook Cho, Dong Hun Cha, Eun Seok Jeon, Jae Joong Kim, Joon Han Shin, Sung Ha Park, Seung Hwan Lee, Sung Hee JohnEun Seok Shin, Nam Ho Kim, Sung Yun Lee, Jun Kwan, Myung Ho Jeong, Sang Wook Kim, Jin Ok Jeong, Dong Woon Kim, Nam Ho Lee, Woo Jung Park, Jeong Cheon Ahn, Kyung Heon Won, Seung Uk Lee, Jang Hyun Cho, Soon Kil Kim, Taehoon Ahn, Sukkeun Hong, Sang Yong Yoo, Song Yi Kim, Byung Soo Kim, Jae Hyeon Juhn, Sun Young Kim, Yu Jeong Lee, Byung Hee Oh

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Abstract

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 ¥.

Original languageEnglish
Pages (from-to)1726-1739
Number of pages14
JournalClinical Therapeutics
Volume37
Issue number8
DOIs
Publication statusPublished - 2015 Aug 1

Keywords

  • combination
  • hypertension
  • lercanidipine
  • valsartan

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Na, S. H., Lee, H. Y., Hong Baek, S., Jeon, H. K., Kang, J. H., Kim, Y. N., Park, C. G., Ryu, J. K., Rhee, M. Y., Kim, M. H., Hong, T. J., Choi, D. J., Cho, S. W., Cha, D. H., Jeon, E. S., Kim, J. J., Shin, J. H., Park, S. H., Lee, S. H., ... Oh, B. H. (2015). Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clinical Therapeutics, 37(8), 1726-1739. https://doi.org/10.1016/j.clinthera.2015.05.512