| Trial ID: | L0997 |
| Source ID: | EUCTR2005-002160-28-AT
|
| Associated Drug: |
Atorvastatin
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| Title: |
Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
|
| Acronym: |
--
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| Status: |
Completed
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| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question wh
|
| Interventions: |
<br>Trade Name: Sortis<br>Product Name: Sortis 10 mg<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Atorvastatin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br>Pharmaceutical form of
|
| Outcome Measures: |
Primary end point(s): LDL-cholesterol (LDL-C);Secondary Objective: Moreover, we aim to test the hypotheses that the cholesterol-lowering effect of atorvastatin and the safety concerning hepatotoxicity in PBC patients does not differ from non-cholestatic, hypercholesterolemic patients.;Main Objective: Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC patients have a very slow progression of their underlying liver disease cardiovascular risk factors may become more relevant as prognostic factors. Statins may reduce serum cholesterol levels and cardiovascular risk in PBC patients although this remains to be determined. Statins are generally well tolerated by patients with nonalcoholic fatty liver disease (NAFLD) and are not associated with an increased risk of hepatotoxicity. In regard to cholestatic liver diseases only limited data on safety of statins are available. Atorvastatin did not statistically increase liver enzymes in PBC patients in a recent pilot study at the Medical University Graz. However, data on long-term treatment with atorvastatin in these patients are not yet available.
|
| Sponsor/Collaborators: |
Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology
|
| Gender: |
All
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| Age: |
--
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| Phases: |
Not applicable
|
| Enrollment: |
80
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: no
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
| Start Date: |
19/08/2005
|
| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
--
|
| Locations: |
Austria
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002160-28
|
