ARIA (Atacand Renoprotection In NephropAthy Pt.)
PCR
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
1 other identifier
interventional
128
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
July 19, 2011
CompletedAugust 23, 2011
August 1, 2011
1.7 years
December 13, 2007
June 17, 2010
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
baseline to 28 weeks
Secondary Outcomes (4)
Change of Systolic and Diastolic Blood Pressure From Baseline
baseline to 28 weeks
Inflammatory Marker (Hs-C-peptide Reactive Protein)
baseline to 28 weeks
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
28 weeks
Treatment-emergent Adverse Events
Baseline to 28 weeks
Study Arms (3)
1
EXPERIMENTALCandesartan Cilexetil
2
EXPERIMENTALCandesartan Cilexetil
3
EXPERIMENTALCandesartan Cilexetil
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Current serum-creatinine \> 265 mmol/L (\>3 mg/dL).
- Current serum-potassium \> 5.5 mmol/L
- Known hypersensitivity to angiotensin (AT)1-receptor blocker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Da Suk Han
Severance Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 14, 2007
Study Start
December 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 23, 2011
Results First Posted
July 19, 2011
Record last verified: 2011-08