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Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment (PLAUDIT)

This study has been completed.
Sponsor:
Collaborator:
Danderyd Hospital
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01035320
First received: December 17, 2009
Last updated: February 25, 2011
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is compare the effects of simvastatin+ezetimibe with those of simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory variables in diabetic patients with or without impaired renal function.


Condition Intervention Phase
Diabetes Mellitus
Renal Impairment
 Drug: Ezetimibe
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. [ Time Frame: 6 weeks, 14-18 weeks, 22-24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 weeks, 14-18 weeks, 22-24 weeks ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: January 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: simvastatin + ezetimibe
Cross-over study with placebo only run-in period. All patients participate in this arm with simvastatin + ezetimibe either as first treatment period (8-10 weeks)or second treatment period (8-10 weeks). The primary comparison is ezetimibe vs. placebo on top of simvastatin. A secondary comparison will be simvastatin vs. placebo run-in.
 Drug: Ezetimibe
After a placebo only run-in period patients (two groups) are treated with simvastatin + ezetimibe and simvastatin + placebo in a cross-over trial. Ezetimibe effects on top of simvastatin will be evaluated as the primary aim; simvastatin effects compared to run-in on placebo will be evaluated as a secondary aim.
Other Names:
  • Simvastatin
  • Ezetrol

Detailed Description:

A detailed study protocol is available.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus type 1 or type 2
  • With or without established microalbuminuria (albumin-to-creatinine ratio (ACR)2,5-25 mg/mmol for men, and 3,5-25 mg/mmol for women, according to ISH and ESC recommended criteria)
  • Glomerular filtration rate (GFR) between 15-60 ml/min/1.73m2 (measured the last 6 months) or GFR >75ml/min/1.73m2. The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
  • Age 18-80 years

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035320

Locations
Sweden
Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Danderyd Hospital
Investigators
Principal Investigator: Paul Hjemdahl, MD, PhD Dept. of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna), Stockholm, Sweden
  More Information

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Hjemdahl, MD, PhD, professor, Clinical Pharmacology Unit, Dept of Medicine, Karolinska University Hospital/Solna
ClinicalTrials.gov Identifier: NCT01035320     History of Changes
Other Study ID Numbers: EudraCT 2004-004416-22 DMK001
Study First Received: December 17, 2009
Last Updated: February 25, 2011
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Simvastatin
Ezetimibe
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013