Protection Against Nephropathy in Diabetes with Atorvastatin

niversity of Manchester (UK)0 个研究点目标入组 119 人开始时间: 2008年4月21日最近更新: 2019年8月26日

试验速览

•1. Type 2 diabetes (defined according to the World Health Organization criteria) previously known to have proteinuria or microalbuminuria
•2. Urinary albumin:creatinine ratio greater than 5 mg/mmol on two consecutive urine samples
•3. Aged over 40
•4. Capable of giving informed consent
•5. Consent to inform General Practitioner of inclusion in study

•1. Urinary protein output >2g/24 hours
•2. Serum creatinine >= 200 µmol/l
•3. Blood pressure >160/90 mmHg at randomisation
•4. Women of child bearing potential
•5. Serum cholesterol >= 7 mmol/l or fasting serum triglycerides >= 6 mmol/l at any visit
•6. Taking >10 mg of atorvastatin at screening
•7. Untreated hypothyroidism
•8. Hepatic dysfunction, transaminase >2 times the upper limit of normal or alkaline phosphatase >1.5 times the upper limit of normal
•9. Any other concomitant illness other than diabetes or its complication likely to effect outcome
•10. Concomitant medication that may interact adversely with HMG-CoA reductase inhibitors or ATII receptor antagonists
•11. Known intolerance of ATII receptor antagonists or HMG-CoA reductase inhibitors
•12. HbA1c >10% at randomisation
•13. Current participation in another clinical trial
•14. Unable to comply with protocol for other reasons
•15. Other lipid lowering medication at randomisation

发起方

niversity of Manchester (UK)