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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00573430
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : July 19, 2011
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Change of Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: baseline to 28 weeks ]
  2. Inflammatory Marker (Hs-C-peptide Reactive Protein) [ Time Frame: baseline to 28 weeks ]
    To evaluate how to reduce and relate with cardiovascular risk

  3. 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)

  4. 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.


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573430


Locations
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Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Da Suk Han Severance Hospital
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00573430    
Other Study ID Numbers: D2452L00015
First Posted: December 14, 2007    Key Record Dates
Results First Posted: July 19, 2011
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by AstraZeneca:
Candesartan Cilexetil
Non-diabetic Nephropathy
hypertension
urine protein creatinine ratio
Additional relevant MeSH terms:
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Kidney Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Candesartan
 Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action