Male and female patients aged >= 18 and =500 mg/g and =90 mg/dL (2.33 mmol/L) and =3 months prior to Visit 1.
Conditions
Interventions
Trade Name: Crestor 5mg
Product Name: Crestor 5mg encapsulated tablet
Product Code: AZD4522
Pharmaceutical Form: Film-coated tablet
Trade Name: Lipitor 40mg
Product Name: Lipitor 40mg encapsulated ta
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study lead-in period at Visit 1, patients must fulfil all of the following criteria: 1. Provision of written informed consent 2. Male or female aged =18 and =70 years 3. Type 1 or 2 diabetes 4. Fasting LDL-C levels collected at Visit 1: =90 mg/dL (2.33 mmol/L) and =180 mg/dL (4.66 mmol/L) if statin naïve (have not received statin treatment for =6 weeks prior to study entry) =70 mg/dL (1.81 mmol/L) and =145 mg/dL (3.75 mmol/L) if receiving lovastatin, fluvastatin, or pravastatin at study entry =60 mg/dL (1.55 mmol/L) and =120 mg/dL (3.11 mmol/L) if receiving simvastatin or atorvastatin at study entry 5. Proteinuria of =2+ on urine dipstick at Visit 1 6. Treatment with ACE inhibitor and/or an ARB for =3 months prior to Visit 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of statin intolerance, statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitor (statin) 2. Previous rosuvastatin use at any time 3. Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test 4. Patients having one or more of the following events within 12 weeks of V1: a myocardial infarction, unstable angina, myocardial revascularization (percutaneous transluminal coronary angioplasty, coronary artery bypass graft surgery or another revascularization procedure) or a transient ischemic attack (TIA) or stroke 5. Moderate to severe congestive cardiac failure (New York Heart Association [NYHA] Class III or IV) ( 6. Patients awaiting a planned myocardial revascularization prior to starting the study 7. History of malignancy (unless a documented disease-free period exceeding 5 years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they have 3 consecutive clear Papanicolaou (Pap) smears 8. Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) >1.5 times ULN at Visit 1 9. Poorly controlled diabetes mellitus based on HbA1c =10% or fasting serum glucose =180 mg/dL at Visit 1 10. History of homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinemia (familial dysbetalipoproteinemia) 11. History of alcohol or drug abuse, or both in the last 5 years 12. Current active liver disease as defined by elevations of >2 x ULN in ALT at Visits 1 or 3 or severe hepatic impairment 13. Unexplained creatine kinase (CK) > 2 x ULN at Visits 1 and 3 14. Participation in another investigational drug study 2.0 mg/dL (177 µmol/L) at Visit 3 18. Any known clinical condition that, in the opinion of the investigator, would require an adjustment of the ACE inhibitor and/or ARBs during the 52-week treatment period 19. Statin therapy after Visit 1. Patients may be either statin naïve or have undergone statin withdrawal at Visit 1 20. Bile acid sequestrant therapy after Visit 2 21. Underlying renal disease attributed to autosomal dominant polycystic kidney disease, intersitial nephritis, HIV (human immunodeficiency virus) nephropathy or ischemic renal disease (i.e. bilateral renal artery stenosis or unilateral renal artery stenosis in a single kidney) 22. Asian ethnicity 23. Involvement in the planning and conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 rom baseline to Week 52 in patients with Type 1 or 2 diabetes, moderate proteinuria and mild hypercholesterolaemia.;Primary end point(s): The primary outcome variable (end point) is the change in urinary protein/creatinine ratio from baseline to Week 52.;Secondary Objective: 1. to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio 2. to evaluate the effects of rosuvastatin and atorvastatin on urinary albumin excretion by evaluation of the change in urinary albumin/creatinine ratio 3. to evaluate the effects of rosuvastatin and atorvastatin on: low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), nonHDL-C, apolipoprotein A1 (ApoA-1), apolipoprotein B (ApoB), TC/HDL-C, LDL-C/HDL-C, nonHDL-C/HDL-C and ApoB/ApoA-1) to explore the relationship between renal effects and lipid changes 4. to evaluate the effects of rosuvastatin and atorvastatin on renal function by evaluation of the change in estimated glomerular filtration rate (GFR) predicted from the Modification of Diet in Renal Disease (MDRD) [Levey et al 1999] equation | — |
Countries
Denmark, Hungary, Italy
Outcome results
None listed