Status:
COMPLETED
Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome
Lead Sponsor:
GWT-TUD GmbH
Collaborating Sponsors:
Technische Universität Dresden
University of Regensburg
Conditions:
Metabolic Syndrome
Dyslipidaemia
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in p...
Eligibility Criteria
Inclusion
- dyslipidemia (triglycerides \>= 150 mg/dl and/or decreased levels of HDL-cholesterol \<40 mg/dl in men or \< 50 mg/dl in women)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00659321
Start Date
January 1 2007
End Date
December 1 2008
Last Update
January 11 2012
Active Locations (1)
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1
GWT-TUD GmbH, Centre for Clinical Studies
Dresden, Germany, 01307