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, Sang-Ho; Park, Sung-Ji; Kim, Eung Ju; Kim, Soo-Joong; Cho, Hyun-Jae; Song, Jong-Min; Shin, Jinho; Park, Jin Joo; Shin, Joon-Han; Han, Kyoo-Rok; Choi, Dong-Ju
- Issue Date
- Jun-2018
- Publisher
- BMC
- Keywords
- Hypertension; Combination; Calcium channel blocker; Angiotensin receptor blocker
- Citation
- TRIALS, v.19
- Indexed
- SCIE
SCOPUS
- Journal Title
- TRIALS
- Volume
- 19
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/2374
- 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.
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