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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00573430
First received: December 13, 2007
Last updated: August 19, 2011
Last verified: August 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 22, 2014