Patients in this study do have symptomes like dyspnea, reduced maximum stress and do have a weakness feeling. We are analysing the endothelial function via the FMD-methode: Before and after a Niaspan-treatment of 6 months.
Conditions
Interventions
Trade Name: Niaspan 500 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinic acid
CAS Number: 59-67-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient information and written informed consent • Patients with endothelial dysfunction shown via an analysing with the FMD- methode • Age between 18 - 70 years • no similar therapy in the anamnesis • estimated life expectancy of at least 5 years • -sufficent renal function (creatinine =1,0 mg/dl and urea = 46 mg/dl for ?; creatinine =1,2mg/dl and urea = 46 mg/dl for ?) sufficient liver function (alanine aminotransferase (ALT) : =45 U/l; AST: =50 U/l; both for ? and ?) • No pregnancy • Highly effective contraception for the time of the therapy and 6 months afterwards. Pearl index=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Coronary vessels disease and othervesels disease like peripheral arterial disease. • Hyperlipoproteinemia • Diabetes mellitrus typ 1 and 2 • Arterial hypertension systolic > 160 mmHg and diastolic > 90 mmHg • Alcohol abuse or history of alcohol abuse • Active tumor disease • Active liver disease like hepatitis B, C • After a chemotherapy in the last 6 months • Less as 6 months after cerebral ischemia • Known neurological and psychiatric illness • Known kidney disease (kreatinin > 1,0 mg/dl for ?, and > 1,2 mg/dl for ?) • Renale Anemia • liver insufficience (total bilirubin >1,0 mg/dl , ALT > 50 U/l and AST > 45 U/l for ? and ?) • Known pregnancy • Women, who would not drive through appropriate preventing (Pearl index > 1) • All exclusion criteria against Niaspan®: Hypersensitivity to nicotinic acid or against a component, known acute gastric ulcer, known hemorrhage • Cotreatment with medicine like hormons, EPO, statine, immunosuppressive drugs • Known HIV-infection • Patients who do not give the allowness to save their data • Patients which are included in an other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Is a treatment with Niaspan leading to an improvement of the endothelial function analysed via FMD-methode.;Secondary Objective: - Is Niaspan mobilizing endothelial progenitor cells? - Has got the treatment with Niaspan®an influence on biomarkers like hsCRP, n-ANP, Pro-BNP, PAI-1, HSP-70, Hemoxygenase? - Is the treatment with Niaspan® influencing parameters like hsCRP, Il-1ß, sVCAM?;Primary end point(s): - Improvement of the endothial function. | — |
Countries
Germany
Outcome results
None listed