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ARIA (Atacand Renoprotection In NephropAthy Pt.)

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-diabetic Nephropathy With Hypertension

Intervention: Candesartan Cilexetil (Drug); Candesartan Cilexetil (Drug); Candesartan Cilexetil 32mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Da Suk Han, Principal Investigator, Affiliation: Severance Hospital

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks

Secondary outcome:

Change of Systolic and Diastolic Blood Pressure From Baseline

Inflammatory Marker (Hs-C-peptide Reactive Protein)

Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation

Treatment-emergent Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Seoul, Korea, Republic of
Additional Information

Starting date: December 2007
Last updated: August 19, 2011

Page last updated: August 20, 2015

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