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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

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dc.contributor.authorJo, Sang-Ho-
dc.contributor.authorPark, Sung-Ji-
dc.contributor.authorKim, Eung Ju-
dc.contributor.authorKim, Soo-Joong-
dc.contributor.authorCho, Hyun-Jae-
dc.contributor.authorSong, Jong-Min-
dc.contributor.authorShin, Jinho-
dc.contributor.authorPark, Jin Joo-
dc.contributor.authorShin, Joon-Han-
dc.contributor.authorHan, Kyoo-Rok-
dc.contributor.authorChoi, Dong-Ju-
dc.date.accessioned2018-10-05T00:29:01Z-
dc.date.available2018-10-05T09:30:47Z-
dc.date.issued2018-06-20-
dc.identifier.citationTrials, 19(1):324ko_KR
dc.identifier.issn1745-6215-
dc.identifier.urihttps://hdl.handle.net/10371/142835-
dc.description.abstractBackground
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.sponsorshipThis 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.isoenko_KR
dc.publisherBioMed Centralko_KR
dc.subjectHypertensionko_KR
dc.subjectCombinationko_KR
dc.subjectCalcium channel blockerko_KR
dc.subjectAngiotensin receptor blockerko_KR
dc.titleS-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trialko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor조상호-
dc.contributor.AlternativeAuthor박성지-
dc.contributor.AlternativeAuthor김응주-
dc.contributor.AlternativeAuthor김수중-
dc.contributor.AlternativeAuthor조현재-
dc.contributor.AlternativeAuthor송종민-
dc.contributor.AlternativeAuthor신진호-
dc.contributor.AlternativeAuthor박진주-
dc.contributor.AlternativeAuthor신중한-
dc.contributor.AlternativeAuthor한규록-
dc.contributor.AlternativeAuthor최동주-
dc.identifier.doi10.1186/s13063-018-2636-1-
dc.language.rfc3066en-
dc.rights.holderThe Author(s).-
dc.date.updated2018-06-24T03:33:50Z-
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