iaspan in combination with fluvastatin compared to fluvastatin-monotherapy fpr patients with metabolic syndrome - niaspan in combination with fluvasttin compared to fluvastatin monotherapy for metabolic syndrome
- Conditions
- metabolic syndrome
- Registration Number
- EUCTR2005-003812-31-DE
- Lead Sponsor
- Abteilung Klinische Chemie, UKL Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
men and postmenopausal women with elevated triglyzerides, decreased HDL-cholesterol (men < 40 mg/dl, women < 50 mg/dl), LDL-cholesterol = 160 mg/dl, + one of the following risk factors:
waist circumference men > 94 cm, women > 88 cm
blood pressure = 130/85 mmHg
fasting glucose = 110 mg/dl
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
lipid-lowering medication, excess alcohol intake, malignant diseases, secondary hyperlipidemias, renal failure, insuline-dependent diabetes mellitus
laboratory: SGOT, SGPT > 3 x ULN, CPK > 5 x ULN
allergic reaction to niaspan or fluvastatin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: change in composition and concentration of atherogenic dense LDL particles with niaspan in combination with fluvastatin compared to fluvastatin monotherapy ;Secondary Objective: change in the following parameters:<br>total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyzerides, lipoprotein(a);Primary end point(s): change in apoB-concentration in dense LDL (LDL- 5 and -6 subfraction) with niaspan 1500 mg in combination with fluvastatin XL 80 mg compared to fluvastatin 80 mg monotherapy
- Secondary Outcome Measures
Name Time Method