| Trial ID: | L0963 |
| Source ID: | EUCTR2009-015703-13-DE
|
| Associated Drug: |
Telmisartan
|
| Title: |
The influence of Telmisartan on insulin resistance and fatty liver in patients suffer from hypertension - InReTel
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Influence of Telmisartan on insulin resistance, hypertension, non-alcoholic fatty liver <br>MedDRA version: 12.0
Level: LLT
Classification code 10020772
Term: Hypertension
<br>MedDRA version: 12.0
Level: LLT
Classification code 10052066
Term: Metabolic s
|
| Interventions: |
<br>Trade Name: Kinzalmono 80 mg<br>Product Name: Kinzalmono 80 mg<br>Product Code: BAY68-9291<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: TELMISARTAN<br>CAS Number: 144701-48-4<br>Concentration unit: mg milligram(s)<br>Concentration type: equa
|
| Outcome Measures: |
Main Objective: Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 6 months after treatment with Telmisartan;Secondary Objective: Improvement of insulin resistance reflected by normalized or increased ISI-Matsuda (> 4) 3 months after treatment with Telmisartan<br>Improvement of insulin resistance reflected by normalized or decreased HOMA-IR (< 2) 3 and 6 months after treatment with Telmisartan<br>Improvement of hypertension measured by blood pressure over 24 h<br>Improvement / normalization of the liver enzymes (gamma-GT, ALT) measured by their serum concentrations<br>Improvement / normalization of tissue structure of liver analyzed by sonography<br>Improvement / normalization of the blood lipids measured by serum concentrations of triglycerids, total cholesterol, HDL and LDL<br>Improvement / normalization of tissue structure of liver analyzed by sonographyferric marker measured by serum concentrations of ferritin, iron and transferrin<br>Improvement / normalization of Body mass index and abdominal girth<br>Improvement / normalization of uric acid measured by the serum concentration;Primary end point(s): Normalization / Increasing of ISI-Matsudanan
|
| Sponsor/Collaborators: |
Klinik f??r Innere Medizin II der Klinikum Chemnitz gGmbH
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
| Start Date: |
02/11/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
17 December 2012
|
| Locations: |
Germany
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015703-13
|
