Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan (ESPECIAL)
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|ClinicalTrials.gov Identifier: NCT01552954|
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Seoul National University Bundang Hospital
Daiichi Sankyo, Inc.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ho Jun Chin, Seoul National University Bundang Hospital
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Chronic Kidney Disease
Behavioral: Intensive education of low salt diet
|Recruitment Details||Patients were selected from 7 centers in Korea (Seoul National University Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Konkuk University Hospital, Dongguk University Ilsan Hospital, Kyung Hee University Medical Center, and Seoul St. Mary’s Hospital) and enrolled from Mar. 2012 to Mar. 2013.|
|Pre-assignment Details||We screened 312 patients before 8 weeks of study initiation, and 269 patients were enrolled. During the 1st 8 weeks of this study (ARB run-in), 13 patients were withdrawn. After that, 256 patients were randomized, 11 participants were dropped out between 8th week and 16th week, and 245 who completed the trial were included in the analysis .|
The major limitation of this study is that we used a 24-hour volume urine collected at a single time point for each follow-up visit. Urine excretion can be influenced by the sodium intake of individual patients at certain point.