S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: Study protocol for a randomized controlled trialopen access
- Authors
- Jo, S.-H.[Jo, S.-H.]; Park, S.-J.[Park, S.-J.]; Kim, E.J.[Kim, E.J.]; Kim, S.-J.[Kim, S.-J.]; Cho, H.-J.[Cho, H.-J.]; Song, J.-M.[Song, J.-M.]; Shin, J.[Shin, J.]; Park, J.J.[Park, J.J.]; Shin, J.[Shin, J.]; Han, K.-R.[Han, K.-R.]; Choi, D.-J.[Choi, D.-J.]
- Issue Date
- 20-Jun-2018
- Publisher
- BioMed Central Ltd.
- Keywords
- Angiotensin receptor blocker; Calcium channel blocker; Combination; Hypertension
- Citation
- Trials, v.19, no.1
- Indexed
- SCIE
SCOPUS
- Journal Title
- Trials
- Volume
- 19
- Number
- 1
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/24137
- DOI
- 10.1186/s13063-018-2636-1
- ISSN
- 1745-6215
- 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. © 2018 The Author(s).
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - Medicine > Department of Medicine > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.