ARIA (Atacand Renoprotection In NephropAthy Pt.)

NCT ID: NCT00573430

Last Updated: 2011-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Non-diabetic Nephropathy With Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Candesartan Cilexetil

Group Type EXPERIMENTAL

Candesartan Cilexetil

Intervention Type DRUG

8 mg oral once daily dose

2

Candesartan Cilexetil

Group Type EXPERIMENTAL

Candesartan Cilexetil

Intervention Type DRUG

16 mg oral once daily dose

3

Candesartan Cilexetil

Group Type EXPERIMENTAL

Candesartan Cilexetil 32mg

Intervention Type DRUG

32 mg oral once daily dose

Interventions

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Candesartan Cilexetil

8 mg oral once daily dose

Intervention Type DRUG

Candesartan Cilexetil

16 mg oral once daily dose

Intervention Type DRUG

Candesartan Cilexetil 32mg

32 mg oral once daily dose

Intervention Type DRUG

Other Intervention Names

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Atacand Atacand Atacand

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Da Suk Han

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Research Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D2452L00015

Identifier Type: -

Identifier Source: org_study_id

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