| Trial ID: | L0706 |
| Source ID: | NCT00257283
|
| Associated Drug: |
Omega-3-Acid Ethyl Esters 90
|
| Title: |
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Omega-3-acid ethyl esters 90
|
| Outcome Measures: |
Primary: Composite endpoint, including either of the following events:|- Acute Myocardial Infarction|- Angina Pectoris, leading to coronary investigation or intervention|- Transient Cerebral Ischemia (TCI)|- Apoplexia cerebri (stroke)|- Peripheral Vascular disease, new symptoms or worsening of old symptoms|- Death | Secondary: - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)|- Efficacy, fatty acid profile for phospholipids fraction|- Efficacy: diet registration, fish score|- Thrombosis and/or stenosis of dialysis graft|- Effect on heart rate variability, substudy of 50 patients at baseline and after three months
|
| Sponsor/Collaborators: |
Sponsor: Pronova BioPharma | Collaborators: Danish Heart Foundation|The Danish Kidney Association|North Jutland County
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-11
|
| Completion Date: |
2005-06
|
| Results First Posted: |
|
| Last Update Posted: |
2008-03-11
|
| Locations: |
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, 9100, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00257283
|
