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

Sponsored by:	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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	139
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2009
Estimated 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

Contacts

Contact: AstraZeneca Korea Clinical Study, Information	82 2 2188 0951	minjee.nam@astrazeneca.com
Contact: Dae Suk Han	82 2 2228 1937	dshan@yumc.yonsei.ac.kr

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Da Suk Han

Severance Hospital

More Information

Responsible Party:	AstraZeneca ( Established Product Medical Science Director )
Study ID Numbers:	D2452L00015
Study First Received:	December 13, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00573430
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Candesartan Cilexetil
Non-diabetic Nephropathy
hypertension
urine protein creatinine ratio

Study placed in the following topic categories:

Candesartan cilexetil
Urologic Diseases
Candesartan
Vascular Diseases

Kidney Diseases
Angiotensin II
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 11, 2009