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Niaspan 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

Niaspan 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003812-31-DE
Enrollment
Unknown
Registered
2006-10-24
Start date
2006-07-27
Completion date
Unknown
Last updated
2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic syndrome

Interventions

Product Name: Niaspan Pharmaceutical Form: Tablet INN or Proposed INN: Nikotinsäure Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Product Name: Locol 80 mg

Sponsors

Abteilung Klinische Chemie, UKL Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: men and postmenopausal women with elevated triglyzerides, decreased HDL-cholesterol (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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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: 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—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026