ARIA (Atacand Renoprotection In NephropAthy Pt.)
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week...
Brief Summary
Official Title: “A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy”
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: August 2009
Intervention(s) in this Clinical Trial
- Drug: Candesartan Cilexetil
- 8 mg oral once daily dose
- Drug: Candesartan Cilexetil
- 16 mg oral once daily dose
- Drug: Candesartan Cilexetil 32mg
- 32 mg oral once daily dose
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Candesartan Cilexetil
- Experimental: 2
- Candesartan Cilexetil
- Experimental: 3
- Candesartan Cilexetil
Outcome Measures for this Clinical Trial
Primary Measures
- The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
- Time Frame: baseline to 28 weeks
Safety Issue?: No
- Time Frame: baseline to 28 weeks
Secondary Measures
- Change of Systolic and Diastolic Blood Pressure From Baseline
- Time Frame: baseline to 28 weeks
Safety Issue?: No
- Time Frame: baseline to 28 weeks
- Inflammatory Marker (Hs-C-peptide Reactive Protein)
- Time Frame: baseline to 28 weeks
Safety Issue?: No
- Time Frame: baseline to 28 weeks
- Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
- Time Frame: 28 weeks
Safety Issue?: No
- Time Frame: 28 weeks
- Treatment-emergent Adverse Events
- Time Frame: Baseline to 28 weeks
Safety Issue?: Yes
- Time Frame: Baseline to 28 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic
- Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
- proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)
Exclusion Criteria:
- Current serum-creatinine > 265 mmol/L (>3 mg/dL).
- Current serum-potassium > 5.5 mmol/L
- Known hypersensitivity to angiotensin (AT)1-receptor blocker
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Da Suk Han Principal Investigator Severance Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573430
Study ID Number: D2452L00015
ClinicalTrials.gov Identifier: NCT00573430
Health Authority: Korea: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00573430
