SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 124Â kb

Dong-Ju Choi (515270)

Eung Kim (3412586)

Hyun-Jae Cho (5431766)

Jin Park (1348803)

Jinho Shin (436859)

Jong-Min Song (5431763)

Joon-Han Shin (515263)

Kyoo-Rok Han (3402920)

Sang-Ho Jo (654344)

Soo-Joong Kim (5431760)

Sung-Ji Park (713142)

Trials

Sang-Ho Jo

Sung-Ji Park

Eung Ju Kim

Soo-Joong Kim

Hyun-Jae Cho

Jong-Min Song

Jinho Shin

Jin Joo Park

Joon-Han Shin

Kyoo-Rok Han

Dong-Ju Choi

Crossref

S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial

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 (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.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&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)

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

SNU Open Repository and Archive

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. Trial registration ClinicalTrials.gov, NCT03226340. Registered on 2 December 2015

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