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Clinical Trials/EUCTR2006-000569-13-DE
EUCTR2006-000569-13-DE
Active, not recruiting
Not Applicable

Influence on the coronary Microcirculation and on myocArdial perfusion Reserve of Niaspan given IN addition to simvastatin in diabEtic patients - MARINE

Cardioangiologisches Centrum Bethanien0 sites40 target enrollmentAugust 29, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Cardioangiologisches Centrum Bethanien
Enrollment
40
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 29, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Cardioangiologisches Centrum Bethanien

Eligibility Criteria

Inclusion Criteria

  • •· Age \> 18 years
  • •· Male or post\-menopausal female patients (no HRT)
  • •· Diabetes mellitus type 2, controlled by metformin and/or sulphonylurea
  • •· HDL \<50mg/dl
  • •· LDL \< 160mg/dl
  • •· TG \< 400mg/dl
  • •· BMI \< 30
  • •· HbA1c \< 8%
  • •· Normal renal function (creatinine \<0\.015g/l
  • •· Normal liver blood tests (AST, ALT \<1\.5x ULN)

Exclusion Criteria

  • •· Prior myocardial infarction, PTCA or CABG
  • •· Severe stenosis that needs intervention
  • •· Secondary causes of hyperlipidemia (except type 2 diabetes)
  • •· Cutaneous and/or tendinous xanthoma
  • •· Non\-controlled hypertension (SBP \> 160 and/or DBP\>90 mm Hg)
  • •· Use of non\-selective beta blockers (propanolol)
  • •· Past or current peptic ulcers
  • •· Insulin treatment
  • •· Regular use of corticosteroids
  • •· Drugs able to modify oxidation parameters (probucol, vitamin E, vitamin C)

Outcomes

Primary Outcomes

Not specified

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