This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

ARIA (Atacand Renoprotection In NephropAthy Pt.) (PCR)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: December 13, 2007
Last updated: August 19, 2011
Last verified: August 2011
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

Condition Intervention Phase
Non-diabetic Nephropathy With Hypertension Drug: Candesartan Cilexetil Drug: Candesartan Cilexetil 32mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks [ Time Frame: baseline to 28 weeks ]
    Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Secondary Outcome Measures:
  • Change of Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: baseline to 28 weeks ]
  • Inflammatory Marker (Hs-C-peptide Reactive Protein) [ Time Frame: baseline to 28 weeks ]
    To evaluate how to reduce and relate with cardiovascular risk

  • Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation [ Time Frame: 28 weeks ]
    GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)

  • Treatment-emergent Adverse Events [ Time Frame: Baseline to 28 weeks ]
    Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.

Enrollment: 128
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Candesartan Cilexetil
Drug: Candesartan Cilexetil
8 mg oral once daily dose
Other Name: Atacand
Experimental: 2
Candesartan Cilexetil
Drug: Candesartan Cilexetil
16 mg oral once daily dose
Other Name: Atacand
Experimental: 3
Candesartan Cilexetil
Drug: Candesartan Cilexetil 32mg
32 mg oral once daily dose
Other Name: Atacand


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00573430

Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: Da Suk Han Severance Hospital
  More Information

Responsible Party: AstraZeneca Identifier: NCT00573430     History of Changes
Other Study ID Numbers: D2452L00015
Study First Received: December 13, 2007
Results First Received: June 17, 2010
Last Updated: August 19, 2011

Keywords provided by AstraZeneca:
Candesartan Cilexetil
Non-diabetic Nephropathy
urine protein creatinine ratio

Additional relevant MeSH terms:
Kidney Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017