Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial
In: Clinical Therapeutics, Jg. 39 (2017-08-01), S. 1628-1638
Online
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Zugriff:
Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension.This Phase II multicenter, randomized, double-blind clinical trial enrolled patients aged 19 years or older with essential hypertension, defined as a mean sitting diastolic BP (msDBP) between 95 and 115 mm Hg, and a mean sitting systolic BP (msSBP) of200 mm Hg after a 2-week placebo run-in period. A total of 635 patients were screened, of whom 439 were randomized to receive treatment; 425 patients were included in the full analysis set (combination therapy, 212; monotherapy, 213). Participants were randomly assigned to receive 1 of 8 treatments: CAN (8 or 16 mg), AML (5 or 10 mg), CAN/AML (8 mg/5 mg, 8 mg/10 mg, 16 mg/5 mg, or 16 mg/10 mg), once daily for 8 weeks.After 8 weeks of treatment, changes in msDBP were significantly greater in the groups receiving CAN/AML combination therapies compared with monotherapies at matched doses, with the exception of CAN 8 mg/AML 10 mg versus AML 10 mg. The response to treatment and the achievement of target BP (both msSBP and msDBP) at week 8 were significantly greater overall in the groups that received combination therapy versus monotherapy. All medications were relatively well tolerated in each group.Eight-week administration of CAN/AML (8 mg/5 mg, 16 mg/5 mg, and 16 mg/10 mg) resulted in a significantly greater BP reduction than that with CAN or AML monotherapy, and was determined to be well tolerated. ClinicalTrials.gov identifier: NCT02944734.
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Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial
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Autor/in / Beteiligte Person: | Ihm, Sang-Hyun ; Seong Mi Park ; Hae Young Lee ; Jang Hyun Cho ; Eun Joo Cho ; Myung Ho Jeong ; Il Suk Sohn ; Ahn, Taehoon ; Chong Jin Kim ; Hui Kyung Jeon ; Young Kwon Kim ; Taek Jong Hong ; Ho Joong Youn ; Woo Shik Kim ; Shung Chull Chae ; Joong Il Park ; Tae Hyun Yang ; Shin, Eun-Seok ; Nam, Chang-Wook ; Jun Hee Lee ; Jung Han Yoon ; Woo Baek Chung ; Ji Yong Choi |
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Zeitschrift: | Clinical Therapeutics, Jg. 39 (2017-08-01), S. 1628-1638 |
Veröffentlichung: | Elsevier BV, 2017 |
Medientyp: | unknown |
ISSN: | 0149-2918 (print) |
DOI: | 10.1016/j.clinthera.2017.06.014 |
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