Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 신진호 | - |
dc.date.accessioned | 2019-12-08T08:33:03Z | - |
dc.date.available | 2019-12-08T08:33:03Z | - |
dc.date.issued | 2018-06 | - |
dc.identifier.citation | TRIALS, v. 19, Article no. 324 | en_US |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2636-1 | - |
dc.identifier.uri | https://repository.hanyang.ac.kr/handle/20.500.11754/119019 | - |
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 (5 mg) or S-amlodipine (2.5 mg) monotherapy for >= 2 weeks and whose mean diastolic blood pressure (DBP) is greater than 90 mmHg will be randomized to either S-amlodipine (2.5 mg) plus chlorthalidone (25 mg) or S-amlodipine (2.5 mg) plus telmisartan (40 mg) therapy. The primary efficacy endpoint is mean sitting DBP change after 12 weeks 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 3 mmHg 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 < 140 mmHg or DBP < 90 mmHg). 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 hospital's 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. | en_US |
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&amp;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). | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | BMC | en_US |
dc.subject | Hypertension | en_US |
dc.subject | Combination | en_US |
dc.subject | Calcium channel blocker | en_US |
dc.subject | Angiotensin receptor blocker | en_US |
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 | en_US |
dc.type | Article | en_US |
dc.relation.volume | 19 | - |
dc.identifier.doi | 10.1186/s13063-018-2636-1 | - |
dc.relation.page | 324-331 | - |
dc.relation.journal | TRIALS | - |
dc.contributor.googleauthor | Jo, Sang-Ho | - |
dc.contributor.googleauthor | Park, Sung-Ji | - |
dc.contributor.googleauthor | Kim, Eung Ju | - |
dc.contributor.googleauthor | Kim, Soo-Joong | - |
dc.contributor.googleauthor | Cho, Hyun-Jae | - |
dc.contributor.googleauthor | Song, Jong-Min | - |
dc.contributor.googleauthor | Shin, Jinho | - |
dc.contributor.googleauthor | Park, Jin Joo | - |
dc.contributor.googleauthor | Shin, Joon-Han | - |
dc.contributor.googleauthor | Han, Kyoo-Rok | - |
dc.relation.code | 2018009081 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | jhs2003 | - |
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