| Trial ID: | L3422 |
| Source ID: | NCT00559286
|
| Associated Drug: |
Telmisartan
|
| Title: |
Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels
|
| Acronym: |
ITEM
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Arterial Hypertension|Diabetes Mellitus Type 2 IRC or NIR
|
| Interventions: |
DRUG: Telmisartan
|
| Outcome Measures: |
Primary: Changes in Elongation-Index (EI) Method: To determine the elongation index (EI) we use the Laser assisted optical rotational cell analyzer (Lorrca)., after 30 days of treatment with study drug/control | Secondary: Improvement of microcirculatory perfusion (using laser doppler measurement), after 30 days treatment|Improvement of endothelial function (using ultrasound measurements during flow mediated dilation), after 30 days treatment|Increase in the total blood born NO pool (using reductive gase phase chemiluminescence, after 30 days treatment|Decrease of RBC aggregation (using Laser assisted optical rotational cell analyzer (Lorrca), after 30 days of treatment
|
| Sponsor/Collaborators: |
Sponsor: RWTH Aachen University | Collaborators: CTCA|Heidelberg University|Bayer
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-12
|
| Completion Date: |
2009-01
|
| Results First Posted: |
|
| Last Update Posted: |
2009-01-29
|
| Locations: |
University Hospital, Aachen, NRW, 52074, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00559286
|
