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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Non-diabetic Nephropathy With Hypertension

Treatments: Drug: Candesartan Cilexetil 32mg; Drug: Candesartan Cilexetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00573430

D2452L00015

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 3 patient groups

1

Experimental group

Description:

Candesartan Cilexetil

Treatment:

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil

2

Experimental group

Description:

Candesartan Cilexetil

Treatment:

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil

3

Experimental group

Description:

Candesartan Cilexetil

Treatment:

Drug: Candesartan Cilexetil 32mg