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S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial
DC Field | Value | Language |
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dc.contributor.author | Jo, Sang-Ho | - |
dc.contributor.author | Park, Sung-Ji | - |
dc.contributor.author | Kim, Eung Ju | - |
dc.contributor.author | Kim, Soo-Joong | - |
dc.contributor.author | Cho, Hyun-Jae | - |
dc.contributor.author | Song, Jong-Min | - |
dc.contributor.author | Shin, Jinho | - |
dc.contributor.author | Park, Jin Joo | - |
dc.contributor.author | Shin, Joon-Han | - |
dc.contributor.author | Han, Kyoo-Rok | - |
dc.contributor.author | Choi, Dong-Ju | - |
dc.date.accessioned | 2018-10-05T00:29:01Z | - |
dc.date.available | 2018-10-05T09:30:47Z | - |
dc.date.issued | 2018-06-20 | - |
dc.identifier.citation | Trials, 19(1):324 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://hdl.handle.net/10371/142835 | - |
dc.description.abstract | Background
The efficacy of a combination of a calcium channel blocker (CCB) plus chlorthalidone (diuretic) versus a CCB plus an angiotensin receptor blocker (ARB) in patients not responding to CCB monotherapy has not been evaluated previously. We plan to compare the efficacy and safety of S-amlodipine (CCB) plus chlorthalidone versus S-amlodipine plus telmisartan (ARB) combinations among hypertension patients unresponsive to amlodipine monotherapy. Methods/design This study is a prospective, randomized, double-blind, multicenter, parallel, non-inferiority phase 4 study. Hypertension patients who have been treated with amlodipine (5mg) or S-amlodipine (2.5mg) monotherapy for ≥2weeks and whose mean diastolic blood pressure (DBP) is greater than 90mmHg will be randomized to either S-amlodipine (2.5mg) plus chlorthalidone (25mg) or S-amlodipine (2.5mg) plus telmisartan (40mg) therapy. The primary efficacy endpoint is mean sitting DBP change after 12weeks of treatment. The study objective is to prove the non-inferiority of the former combination (test drug) as compared to the latter one (control) with a non-inferiority margin of 3mmHg in mean DBP change. The secondary endpoints are 6-week DBP change, 6- and 12-week sitting systolic BP (SBP) change, and the attainment of the target BP (SBP < 140mmHg or DBP < 90mmHg). Urine albumin, albumin/creatinine ratio (ACR), pulse wave velocity, central BP, 24-h ambulatory BP monitoring, and body fluid composition analysis will be performed at each hospitals discretion. The sample size was estimated as 170 in total with 1:1 randomization. Discussion This is the first study comparing the efficacy of a CCB plus chlorthalidone versus a CCB plus an ARB in patients who are not responding to CCB single therapy. The study result will help clinicians to choose between chlorthalidone and telmisartan in CCB-unresponsive patients. Trial registration ClinicalTrials.gov, NCT03226340. Registered on 2 December 2015. | ko_KR |
dc.description.sponsorship | This research was supported by Hanlim Pharmaceutical Co., Ltd., Korea, under the programs of the Seoul National University Bundang Hospital (SNUBH) research support (Subject No.: 06-2015-203 and IRB No.: B-1507/307-005) and was partly supported by the ITECH R&D program of MOTIE/KEIT (Project No. 10053597, Development of High-Speed Signal Processing IC and Platform for Contactless Monitoring of Bio-Signal in Vehicle). | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Hypertension | ko_KR |
dc.subject | Combination | ko_KR |
dc.subject | Calcium channel blocker | ko_KR |
dc.subject | Angiotensin receptor blocker | ko_KR |
dc.title | S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 조상호 | - |
dc.contributor.AlternativeAuthor | 박성지 | - |
dc.contributor.AlternativeAuthor | 김응주 | - |
dc.contributor.AlternativeAuthor | 김수중 | - |
dc.contributor.AlternativeAuthor | 조현재 | - |
dc.contributor.AlternativeAuthor | 송종민 | - |
dc.contributor.AlternativeAuthor | 신진호 | - |
dc.contributor.AlternativeAuthor | 박진주 | - |
dc.contributor.AlternativeAuthor | 신중한 | - |
dc.contributor.AlternativeAuthor | 한규록 | - |
dc.contributor.AlternativeAuthor | 최동주 | - |
dc.identifier.doi | 10.1186/s13063-018-2636-1 | - |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s). | - |
dc.date.updated | 2018-06-24T03:33:50Z | - |
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