Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
NCT01094158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2012-01-31
Summary
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.
Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.
Conditions
- Non-Alcoholic Fatty Liver Disease
- Nonalcoholic Steatohepatitis
- Metabolic Syndrome
Interventions
- DRUG
-
Aramchol
100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
- DRUG
-
Aramchol
300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
- DRUG
-
tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast
Sponsors & Collaborators
-
Tel-Aviv Sourasky Medical Center
collaborator OTHER_GOV -
Beilinson Hospital, Petach Tikva,Israel
collaborator UNKNOWN -
Meir Medical Center
collaborator OTHER -
Kaplan Hospital ,Rehovot,Israel
collaborator UNKNOWN -
Soroka Hospital,Beer Sheva,Israel
collaborator UNKNOWN -
Hadassah Medical Organization
collaborator OTHER -
Hillel Yaffe Medical Center
collaborator OTHER_GOV -
Rambam Hospital, Haifa, Israel
collaborator UNKNOWN -
The Lady Davis Carmel Medical Center
collaborator UNKNOWN -
Holy Family Hospital, Nazareth, Israel
collaborator OTHER -
Ziv Hospital
collaborator OTHER_GOV -
Galmed Medical Reserch
lead INDUSTRY
Principal Investigators
-
Ran Oren, Doctor · Liver & Gastroenterology Department,The Tel Aviv Sourasky Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2011-11-30
- Completion
- 2012-01-31
Countries
- Israel
Study Locations
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