| Trial ID: | L1770 |
| Source ID: | NCT01035320
|
| Associated Drug: |
Ezetimibe
|
| Title: |
Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
|
| Acronym: |
PLAUDIT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Impaired Renal Function
|
| Interventions: |
DRUG: Ezetimibe
|
| Outcome Measures: |
Primary: Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2., 6 weeks, 14-18 weeks, 22-24 weeks | Secondary: Compare effects of simvastatin alone with those of placebo on thrombogenic mechanisms. Compare the effects of simvast. + ezetim. with those of simvast. alone on inflammatory variables. Assess how the treatment effect relate to renal function., 6 weeks, 14-18 weeks, 22-24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Karolinska Institutet | Collaborators: Danderyd Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
39
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-01
|
| Completion Date: |
2012-06
|
| Results First Posted: |
|
| Last Update Posted: |
2021-03-01
|
| Locations: |
Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna), Stockholm, 171 76, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT01035320
|
