Il Suk Sohn1, Chong-Jin Kim2, Taehoon Ahn3, Ho-Joong Youn4, Hui-Kyung Jeon5, Sang Hyun Ihm6, Eun Joo Cho7, Woo-Baek Chung8, Shung Chull Chae9, Woo-Shik Kim10, Chang-Wook Nam11, Seong-Mi Park12, Ji-Yong Choi13, Young-Kwon Kim14, Taek-Jong Hong15, Hae-Young Lee16, Jang-Hyun Cho17, Eun-Seok Shin18, Jung-Han Yoon19, Tae-Hyun Yang20, Myung-Ho Jeong21, Jun-Hee Lee22, Joong-Il Park23. 1. Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea. 2. Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea. Electronic address: chongjinkim@naver.com. 3. Gachon University Gil Medical Center, Incheon, Republic of Korea. 4. Seoul St. Mary׳s Hospital, Catholic University of Korea, Seoul, Republic of Korea. 5. Uijeongbu St. Mary׳s Hospital, Catholic University of Korea, Uijeongbu, Republic of Korea. 6. Bucheon St. Mary׳s Hospital, Catholic University of Korea, Bucheon, Republic of Korea. 7. St. Paul׳s Hospital, Catholic University of Korea, Seoul, Republic of Korea. 8. Yeouido St. Mary׳s Hospital, Catholic University of Korea, Seoul, Republic of Korea. 9. Kyungpook National University Hospital, Daegu, Republic of Korea. 10. Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea. 11. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea. 12. Korea University Anam Hospital, Korea University, Seoul, Republic of Korea. 13. Daegu Catholic University Medical Center, Daegu, Republic of Korea. 14. Dongguk University Medical Center, Ilsan, Republic of Korea. 15. Pusan National University Hospital, Busan, Republic of Korea. 16. Seoul National University Hospital, Seoul National University, Seoul, Republic of Korea. 17. St. Carollo Hospital, Suncheon, Republic of Korea. 18. Ulsan University Hospital, Ulsan, Republic of Korea. 19. Wonju Severance Christian Hospital, Wonju, Republic of Korea. 20. Inje University Busan Paik Hospital, Busan, Republic of Korea. 21. Chonnam National University Hospital, Chonnam National University, Gwangju, Republic of Korea. 22. Kangdong Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea. 23. Seoul Veterans Hospital, Seoul, Republic of Korea.
Abstract
PURPOSE: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. METHODS: 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) of <200 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. FINDINGS: 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. IMPLICATIONS: 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.
RCT Entities:
PURPOSE: 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. METHODS: 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) of <200 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. FINDINGS: 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. IMPLICATIONS: 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.