Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis
NALCAT
Comparison the Effectiveness of L-Carnitine With Atorvastatin in Non-Alcoholic Steatohepatitis (NASH)
1 other identifier
interventional
440
1 country
2
Brief Summary
The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2016
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 11, 2018
May 1, 2018
3.8 years
June 8, 2012
May 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement in liver stiffness
As measured by Fibroscan
2 years
Secondary Outcomes (2)
improvement in liver enzyme levels
2 years
Adverse drug events
2 years
Study Arms (4)
Atorvastatin
EXPERIMENTAL20mg atorvastatin daily
Carnitine
EXPERIMENTAL1000mg L-carnitine daily
Atoral
EXPERIMENTAL1000mg L-carnitine and 20mg atorvastatin
Placebo
PLACEBO COMPARATORIdentically looking placebo
Interventions
Eligibility Criteria
You may qualify if:
- NASH diagnosed on the basis of the following criteria:
- Imaging techniques showing evidence of hepatic steatosis
- Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.
You may not qualify if:
- Patients with hepatitis B or C
- alanine transaminase \> 300 IU/L
- Participants presenting one or more causes commonly associated with secondary NAFLD (drugs, surgical procedures, environmental toxins, or total parenteral nutrition)
- Alcohol ingestion greater than 40 gr per week
- Abnormal Lipid profile (TG\>500 , LDL\>160)
- Patients with hypertension, diabetes mellitus, coronary heart disease
- Fibroscan score more than 14 kp
- pregnancy, lactation
- Drug addiction
- Reynolds Risk Score \> 10%
- Not consenting to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pars Cohort Center
Shiraz, Fars, Iran
Masoud Clinic
Tehran, 14117, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Reza Malekzadeh, MD
Tehran University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
January 1, 2016
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
May 11, 2018
Record last verified: 2018-05