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Clinical Trials/EUCTR2005-002597-30-DE
EUCTR2005-002597-30-DE
Active, not recruiting
Not Applicable

Placebokontrollierte Untersuchung zur Wirkung von Nikotinsäure auf die Dyslipidämie bei Metabolischem Syndrom und das Arterioskleroserisiko - Niaspan

Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH0 sitesNovember 3, 2005
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ConditionsDyslipidemia (Hypertriglyzeridemia and/or low HDL-cholersterol) with metabolic syndrome
DrugsNiaspan RetardtablettenNiaspan Retardtabletten 1000 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dyslipidemia (Hypertriglyzeridemia and/or low HDL-cholersterol) with metabolic syndrome
Sponsor
Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 3, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH

Eligibility Criteria

Inclusion Criteria

  • •Patients with dyslipidemia (triglycerides \>\= 150 mg/dl and/or decreased levels of HDL\-cholesterol \<40 mg/dl in men or \< 50 mg/dl in women) and with further components of the metabolic syndrome:
  • •Hypertension: blood pressure \>\= 130/85 mmHg or/and
  • •Hyperglycemia: fasting plasma glucose \>\= 100 mg/dl or/and
  • •2 hour plasma glucose after 75g glucose load (OGTT) \>\= 140 mg/dl or/and
  • •Obesity: waist circumferences \> 102 cm in men or \>88 cm in women
  • •age between 30 and 75 years
  • •informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •\-Contraindication and incompatibility of nicotine acid
  • •\-Patients with ulcus ventriculi or ulcus duodeni
  • •\-Intake of lipid lowering drugs \< 6 weeks before randomization
  • •\-therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono\-therapy with metformin or sulfonyl urea is permit)
  • •\-no acceptable therapy of diabetes with levels of HbA1C\>\=8\.0%
  • •\-cardiovascular events in the last 6 months
  • •\-chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
  • •\-ALAT elevation 2\.5 times more than the normal limit
  • •\-pregnancy

Outcomes

Primary Outcomes

Not specified

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