Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan (ESPECIAL)

This study has been completed.
Sponsor:
Collaborators:
Daiichi Sankyo Inc.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ho Jun Chin, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01552954
First received: February 24, 2012
Last updated: December 10, 2014
Last verified: December 2014
  Purpose

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.

Condition Intervention Phase
Hypertension
Chronic Kidney Disease
Microalbuminuria
Behavioral: Intensive education of low salt diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Low Sodium Intake on the Anti-proteinuric Efficacy of Olmesartan in Hypertensive Patients With Albuminuria Through Open-label Randomized Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • ∆Albuminuria by 24-hour Urine Protein Excretion [ Time Frame: changes from week 8 at week 16 (week 8 - week 16) ] [ Designated as safety issue: No ]

    Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan

    *In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were "mean" of all participants on specific study week, but "∆albuminuria (week 8 - week 16)" value was "mean" of ∆ values of "8 weeks-16 weeks" in each individuals. Therefore, values of 3 patients were excluded in "mean of ∆albuminuria (week 8 - week 16)". That's why simple subtraction (week 8 - week 16) of values are not matched with the data.



Secondary Outcome Measures:
  • ∆Hemoglobin (0 Week - 16 Weeks) [ Time Frame: 0 week, 16 weeks ] [ Designated as safety issue: No ]
    The change of hemoglobin after prescription of Olmesartan

  • Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16 [ Time Frame: week 8 and week 16 ] [ Designated as safety issue: No ]
    Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16

  • Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16 [ Time Frame: week 8 and week 16 ] [ Designated as safety issue: No ]
    Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group


Enrollment: 269
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive education of low salt diet
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. (*Intervention in this trial is the "intensity of education")
Behavioral: Intensive education of low salt diet
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.
Other Names:
  • low salt diet
  • Angiotensin II converting enzyme
  • albuminuria
  • chronic kidney disease
No Intervention: Conventional diet group
Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 19 years or more and 75 years or less
  • Hypertension patients: Patients whose blood pressure is 140/90mmHg and over, patients is newly diagnosed with hypertension or is prescribed antihypertensive medications.
  • Hypertensive patients verified 2 times or more of albuminuria 30 mg/g cr or more in a spot urine sample with interval of 1 week or more in recent 6 months
  • Estimated glomerular filtration rate (GFR) by Modification of Diet in Renal Disease (MDRD) equation 30 ml/min/1.73 m2 or more
  • Patients who give written consent to this study by oneself

Exclusion Criteria:

  • Blood pressure more than 160/100 mmHg
  • Pregnant
  • Serum potassium level more than 5.5 mEq/L at screening period
  • Patients with malignancy, acute cerebral infarction, acute myocardial infarction, unstable angina, percutaneous coronary arterial intervention (PCI), or coronary artery bypass graft (CABG) in recent 6 months
  • Patients with diabetes mellitus
  • Patients who have an allergy to Olmesartan
  • Patients who were involved in other clinical trial in recent 1 month or are participated in screening period
  • Patients taking medication(s) of corticosteroid or immunosuppressant in a screening period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552954

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyeong ki, Korea, Republic of, 463787
Dongguk University Ilsan Hospital
Ilsan, Kyeongki, Korea, Republic of, 410773
Konkuk University School of Medicine
Seoul, Korea, Republic of, 143729
Kyung Hee University
Seoul, Korea, Republic of, 134727
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137701
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Daiichi Sankyo Inc.
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Ho Jun Chin, PhD Seoul National University Bundang Hospital
Study Chair: Chun-Soo Lim, PhD SMG-SNU Boramae Medical Center
Principal Investigator: Dong Ki Kim, PhD Seoul National University Hospital
Principal Investigator: Suhnggwon Kim, PhD Seoul National University Hospital
Principal Investigator: Bum Soon Choi, PhD Seoul St. Mary's Hospital
Principal Investigator: Sang-Ho Lee, PhD Kyung Hee University
Principal Investigator: Jung-Hwan Park, PhD Konkuk University
Principal Investigator: Sung Joon Shin, PhD DongGuk University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ho Jun Chin, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01552954     History of Changes
Other Study ID Numbers: B-1112/142-008
Study First Received: February 24, 2012
Results First Received: October 30, 2013
Last Updated: December 10, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
hypertension
Chronic kidney disease
albuminuria
low salt diet
Angiotensin II receptor blocker

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on March 26, 2015