Phase 4
N=256
Effects of Low Sodium Intake on the Anti-proteinuric Efficacy in Hypertensive Patient With Olmesartan
Hypertension · Chronic Kidney Disease · Microalbuminuria
Bottom Line
View on ClinicalTrials.gov: NCT01552954 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: ∆Albuminuria by 24-hour Urine Protein Excretion — 483.5; 569.9; 487.3; 417.4 mg/day — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intensive education of low salt diet (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Seoul National University Bundang Hospital
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ∆Albuminuria by 24-hour Urine Protein Excretion |
483.5; 569.9; 487.3; 417.4; -0.4; 154.0 | 0.006 sig |
| SECONDARY ∆Hemoglobin (0 Week - 16 Weeks) |
13.8; 14.0; 13.5; 13.7; 13.3; 13.4 | 0.187 |
| SECONDARY Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16 |
155.5; 157.4; 147.1; 122.1; 9.0; 35.4 | 0.001 sig |
| SECONDARY Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16 |
121.8; 122.1; 121.2; 120.4; 0.6; 1.7 | >0.05 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01552954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.