Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (PLANET 1)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00296374

D3569C00007

PLANET 1

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hyperlipidemia
• urinary protein
• diabetes

Exclusion criteria

• previous rosuvastatin treatment < 6 months prior to Visit 1
• statin intolerance
• severe hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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353 participants in 3 patient groups

1

Experimental group

Description:

Rosuvastatin 10 mg

Treatment:

Drug: Rosuvastatin

Drug: Rosuvastatin

2

Experimental group

Description:

Rosuvastatin 40 mg

Treatment:

Drug: Rosuvastatin

Drug: Rosuvastatin

3

Active Comparator group

Description:

Atorvastatin 80 mg

Treatment:

Drug: Atorvastatin