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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

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:

The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Secondary Outcome Measures:

Change of Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
Inflammatory Marker (Hs-C-peptide Reactive Protein) [ Time Frame: baseline to 28 weeks ] [ Designated as safety issue: No ]
To evaluate how to reduce and relate with cardiovascular risk
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
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)
Treatment-emergent Adverse Events [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: Yes ]
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.

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
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

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 < 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

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
ClinicalTrials.gov Identifier:	NCT00573430 History of Changes
Other Study ID Numbers:	D2452L00015
Study First Received:	December 13, 2007
Results First Received:	June 17, 2010
Last Updated:	August 19, 2011
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:

Hypertension
Kidney Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Candesartan cilexetil
Candesartan

Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012