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| [ Print-friendly version ] |
| Protection Against Nephropathy in Diabetes with Atorvastatin |
| ISRCTN | ISRCTN58196433 |
| ClinicalTrials.gov identifier | |
| Public title | Protection Against Nephropathy in Diabetes with Atorvastatin |
| Scientific title | |
| Acronym | PANDA |
| Serial number at source | N/A |
| Study hypothesis | To compare the effect of treatment with a low and high dose HMG CoA reductase inhibitor on the progression of diabetic nephropathy in patients with type II diabetes whose blood pressure will be controlled using antihypertensive regimens that will include angiotensin II receptor antagonists. |
| Ethics approval | Central Manchester Research Ethics Committee. Date of approval: 28/07/2004 (ref: 04/Q1407/51) |
| Study design | A double-blinded parallel study, randomised by block design and stratified by centre. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Type II diabetes with proteinuria |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 19/11/2004 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 200 |
| Interventions | 1 x 10 mg active atorvastatin (oral) and 2 x 40 mg placebo vs 2 x 40 mg active atorvastatin (oral) and 1 x 10 mg placebo for three years. |
| Primary outcome measure(s) |
1. Difference in the mean level of glomerular filtration rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily
2. Difference in the mean level of albumin excretion rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily |
| Secondary outcome measure(s) |
1. Change in serum creatinine and GFR between baseline and 3 years follow-up for patients receiving atorvastatin 10 mg and 80 mg daily
2. Difference in the mean level of serum creatinine at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 3. Difference in the percentage of patients achieving low density lipoprotein (LDL) cholesterol levels <2.6 mmol/l at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 4. Difference in the percentage of patients who have a cardiovascular event defined as documented non fatal acute myocardial infarction, hospital admission for unstable angina, appearance of new Q waves on electrocardiogram (ECG), coronary heart disease (CHD) death, coronary artery bypass surgery, coronary angioplasty/stenting or lower limb revascularisation, ischaemic stroke shown by abnormal brain scan or permanent neurological deficit, amputation 5. Difference in the percentage of patients who need photocoagulation for diabetic retinopathy within the first 3 years of follow-up between patients receiving atorvastatin 10 mg and 80 mg daily |
| Sources of funding |
1. Pfizer UK Ltd (UK)
2. University of Manchester (Grant ref: R011264) (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Paul Durrington |
| Address |
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor) 46 Grafton Street |
| City/town | Manchester |
| Zip/Postcode | M13 9NT |
| Country | United Kingdom |
| Tel | +44 (0)161 275 1201 |
| Fax | +44 (0)161 275 1183 |
| pdurrington@manchester.ac.uk | |
| Sponsor | University of Manchester (UK) |
| Address |
c/o Prof Paul Durrington
Division of Cardiovascular and Endocrine Science Core Technology Facility (3rd floor) 46 Grafton Street |
| City/town | Manchester |
| Zip/Postcode | M13 9NT |
| Country | United Kingdom |
| Tel | 0161 275 1201 |
| Fax | 0161 275 1183 |
| pdurrington@manchester.ac.uk | |
| Sponsor website: | http://www.manchester.ac.uk |
| Date applied | 14/02/2008 |
| Last edited | 21/04/2008 |
| Date ISRCTN assigned | 21/04/2008 |
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