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 : EUCTR2005-002508-41

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 Non-Diabetic Patients with Moderate Proteinuria PLANET II: Prospective evaLuation of proteinuriA and reNal function in non-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 non-diabetic patients with moderate proteinuria and hypercholesterolaemia.


Critère d'inclusion

  • Male and female, non-diabetic patients aged ≥18 with 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 receiving current treatment with ACE (Angiotensin converting enzyme) inhibitors and/or ARBs (Angiotensin receptor blockers) for ≥3 months prior to Visit 1