CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 269 enrolled
Drug / intervention
Intensive education of low salt dietbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01552954
NCT01552954Phase 4Completed
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Effects of Low Sodium Intake on the Anti-proteinuric Efficacy of Olmesartan in Hypertensive Patients With Albuminuria Through Open-label Randomized Trial

Seoul National University Bundang Hospital·interventional·Posted Mar 13, 2012·Updated Dec 18, 2014

In Brief

A Phase 4 clinical trial evaluating Intensive education of low salt diet for Hypertension and 2 related conditions. Completed, enrolled 269 participants across 7 sites.

Detailed Summary

Purpose of this study 1. Intensive education for low salt diet will be enhance the anti-proteinuric effect of Olmesartan, a popular anti-hypertensive drug of angiotensin II receptor blocker, in Koreans compared to conventional prescription of medication. 2. Intensive education for low salt diet will decrease the amount of 24 hour-urine sodium excretion compared to control group, effectively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Chronic Kidney Disease, Microalbuminuria
CountriesSouth Korea
CollaboratorsDaiichi Sankyo, Daewoong Pharmaceutical Co. LTD.

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago

Interventions

Intensive education of low salt dietbehavioral

For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.