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 | 2021-09-02T10:05:46Z | - |
dc.date.available | 2021-09-02T10:05:46Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2018-06-20 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/74905 | - |
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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.subject | COMBINATION THERAPY | - |
dc.subject | CALCIUM-ANTAGONIST | - |
dc.subject | HIGH-RISK | - |
dc.subject | HYDROCHLOROTHIAZIDE | - |
dc.subject | REDUCTION | - |
dc.subject | VALSARTAN | - |
dc.subject | OUTCOMES | - |
dc.subject | DISEASE | - |
dc.subject | HEALTH | - |
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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Eung Ju | - |
dc.identifier.doi | 10.1186/s13063-018-2636-1 | - |
dc.identifier.scopusid | 2-s2.0-85048894295 | - |
dc.identifier.wosid | 000435865700002 | - |
dc.identifier.bibliographicCitation | TRIALS, v.19 | - |
dc.relation.isPartOf | TRIALS | - |
dc.citation.title | TRIALS | - |
dc.citation.volume | 19 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.subject.keywordPlus | COMBINATION THERAPY | - |
dc.subject.keywordPlus | CALCIUM-ANTAGONIST | - |
dc.subject.keywordPlus | HIGH-RISK | - |
dc.subject.keywordPlus | HYDROCHLOROTHIAZIDE | - |
dc.subject.keywordPlus | REDUCTION | - |
dc.subject.keywordPlus | VALSARTAN | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | DISEASE | - |
dc.subject.keywordPlus | HEALTH | - |
dc.subject.keywordAuthor | Hypertension | - |
dc.subject.keywordAuthor | Combination | - |
dc.subject.keywordAuthor | Calcium channel blocker | - |
dc.subject.keywordAuthor | Angiotensin receptor blocker | - |
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