ARIA(Atacand Renoprotection In NephropAthy Pt.) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00573430

Purpose

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 IV

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in urinary protein/creatinine ratio [ Time Frame: Assessed at each visit for 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systolic and diastolic blood pressure [ Time Frame: Assessed at each visit for 28 weeks ] [ Designated as safety issue: No ]
Inflammatory marker (hs-CRP) [ Time Frame: Assessed at each visit for 28 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
Safety [ Time Frame: Assessed at each visit for 28 weeks ] [ Designated as safety issue: No ]

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
1: Experimental Candesartan Cilexetil 8mg	Drug: Candesartan Cilexetil 8 mg oral once daily dose
2: Experimental Candesartan Cilexetil 16mg	Drug: Candesartan Cilexetil 16 mg oral once daily dose
3: Experimental Candesartan Cilexetil 32mg	Drug: Candesartan Cilexetil 32mg 32 mg oral once daily dose

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573430

Locations

Korea, Republic of
Research Site
Seoul, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Da Suk Han

Severance Hospital

More Information

No publications provided

Responsible Party:	AstraZeneca ( Established Product Medical Science Director )
Study ID Numbers:	D2452L00015
Study First Received:	December 13, 2007
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00573430 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Candesartan Cilexetil
Non-diabetic Nephropathy
hypertension
urine protein creatinine ratio

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers

Urologic Diseases
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Kidney Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010