iaspan for the treatment of endothelial dysfunction in patients without hyperlipoproteinemia - ENDOTHE

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2007-002023-32-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-04
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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<1, for example: contraceptive pill, loop, hormone implant, transdermal applicator, a combination of two barrier methods (e.g. condom and diaphragm), sterilization, sexual abstinence.
• Accessibility of the patient for treatment and follow-up
• Compliance of the the patient
• Not included the last 3 months in an other clinical trial
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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>- Has got the treatment with Niaspan®an influence on biomarkers like hsCRP, <br> n-ANP, Pro-BNP, PAI-1, HSP-70, Hemoxygenase?<br>- Is the treatment with Niaspan® influencing parameters like hsCRP, Il-1ß, sVCAM?;Primary end point(s): - Improvement of the endothial function.