Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome
NCT ID: NCT00659321
Last Updated: 2012-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2007-01-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
nicotine acid
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
2
16 weeks treatment with placebo
placebo
16 weeks treatment with placebo
Interventions
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nicotine acid
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
placebo
16 weeks treatment with placebo
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
University of Regensburg
OTHER
GWT-TUD GmbH
OTHER
Responsible Party
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Principal Investigators
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Markolf Hanefeld, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
GWT-TUD GmbH
Locations
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GWT-TUD GmbH, Centre for Clinical Studies
Dresden, , Germany
Countries
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Other Identifiers
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NIASPAN-DD-2005
Identifier Type: -
Identifier Source: org_study_id
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