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: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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 8mg
• Experimental: 2
  • Candesartan Cilexetil 16mg
• Experimental: 3
  • Candesartan Cilexetil 32mg

Primary Measures

• Change in urinary protein/creatinine ratio
  • Time Frame: Assessed at each visit for 28 weeks
    Safety Issue?: No

Secondary Measures

• Systolic and diastolic blood pressure
  • Time Frame: Assessed at each visit for 28 weeks
    Safety Issue?: No
• Inflammatory marker (hs-CRP)
  • Time Frame: Assessed at each visit for 28 weeks
    Safety Issue?: No
• Estimated GFR predicted from the Modification of Diet in Renal Disease (MDRD) equation
  • Time Frame: Assessed at each visit for 28 weeks
    Safety Issue?: No
• Safety
  • Time Frame: Assessed at each visit for 28 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. hypertension; a)135mmHg<SBP<180mmHg and/or 85mmHg<DBP<100mmHg. or b) The subject has been treated with antihypertensive medication
• 2. proteinuria(urinary protein/creatinine ratio between 500mg/g and 5000mg/g)

Exclusion Criteria:

• 1. Current serum-creatinine >265 mmol/L (>3 mg/dL).
• 2. Current serum-potassium >5.5mmol/L
• 3. Known hypersensitivity to AT1-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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Da Suk Han Principal Investigator Severance Hospital  

Overall Contact: AstraZeneca Korea Clinical Study, Information 82 2 2188 0951 minjee.nam@astrazeneca.com

Information obtained from ClinicalTrials.gov on January 08, 2009

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