EUCTR2004-004416-22-SEActive, not recruitingPhase 1
Platelet function in diabetic patients without and with renal impairment, and the effects of lipid-lowering treatment
Karolinska Institutet, Dept of Medicine, Clinical Pharmacology Unit0 sites60 target enrollmentStarted: December 6, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Diabetes mellitus type 2
- •With or without established microalbuminuria (urinary albumin excretion of 30-299 µg/mg creatinine in a spot sample) Two out of three specimens collected within a 3-6 month period should be abnormal before the diagnosis can be settled.
- •Glomerular filtration rate (GFR) between 15-50 ml/min (measured the last 6 months) or GFR >75ml/min. GFR will be established by 24-hour Iohexolclearence.
- •Age 18-80 years
- •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
- •Definite history of myocardial infarction, coronary revascularisation procedure or stroke. (i.e, a strong clinical indication for statin treatment)
- •Functioning renal transplant, or living donor-related transplant planned.
- •Patients on dialysis.
- •Poor metabolic control, i.e HbA1c > 9%
- •Definite history of chronic liver disease, or abnormal liver function (i.e ALT >1,5 x ULN or, if ALT not available, AST > 1,5 x ULN).
- •Evidence of active inflammatory muscle disease (e.g dermatomyositis, polymyositis), or CK>3 x ULN
- •Definite previous adverse reaction to a statin or to ezetimibe
- •Definite previous adverse reaction to acetylsalicylic acid.
- •Definite previous adverse reaction to an ACE-inhibitor.
- •Need for concomitant treatment with a strong inhibitor of CYP3A4, such as itrokonazole, ketokonazole, erythromycin, clarithromycin, HIV-protease inhibitors or nefazodone (i.e. agents that may markedly elevate simvastatin levels).
Investigators
Similar Trials
Withdrawn
Not Applicable
Platelet reactivity in diabetic patients and the effects of different antithrombotic agents on the results of multiple platelet function testsdiabetes mellitus type 210018424DiabetesNL-OMON34970Internal Medicine600
Active, not recruiting
Not Applicable
se of platelet eyedrops in diabetic patients with dry eye disease.dry eye diseasediabetesC11.496.260RBR-96t463Hemocentro de Alagoas-HEMOA
Completed
Not Applicable
Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic eventPatients with ACS or elective indications undergoing PCI with drug-eluting stent implantation.JPRN-UMIN000020332Toho University Ohashi Medical Center6,422
Active, not recruiting
Phase 1
Antiplatelet treatment in patients with diabetes mellitus: is there a difference between aspirin, clopidogrel and prasugrel - Antiplatelet Treatment in DiabetesType 2 diabetes mellitusEUCTR2009-011907-22-GBniversity of Leeds56
Completed
Phase 2
Antiplatelet Treatment in DiabetesTopic: Diabetes Research NetworkSubtopic: Type 2Disease: Cardiovascular diseaseNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitusISRCTN79817966niversity of Leeds (UK)56