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A Randomised, Double-Blind, 52-Week, Parallel-Group, Multicentre, Phase IIb Study to Evaluate the Effects of Rosuvastatin 10 mg, Rosuvastatin 40 mg and Atorvastatin 80 mg on Urinary Protein Excretion ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-002510-38

A Randomised, Double-Blind, 52-Week, Parallel-Group, Multicentre, Phase IIb Study to Evaluate the Effects of Rosuvastatin 10 mg, Rosuvastatin 40 mg and Atorvastatin 80 mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients with Moderate Proteinuria PLANET I: Prospective evaLuation of proteinuriA and reNal function in diabETic patients with progressive renal disease

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Extrait

The primary objective of this study is to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio from baseline to Week 52 in patients with Type 1 or 2 diabetes, moderate proteinuria and hypercholesterolaemia.

Critère d'inclusion

  • Male and female patients aged >= 18 years with Type 1 or 2 diabetes, moderate proteinuria (baseline urinary protein/creatinine ratio >=500 mg/g and <=5000 mg/g), hypercholesterolaemia (fasting LDL-C >=90 mg/dL (2.33 mmol/L) and <180 mg/dL (4.66 mmol/L) and receiving current treatment with ACE (Angiotensin converting enzyme) inhibitors and/or ARBs (Angiotensin receptor blockers) for >=3 months prior to Visit 1

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