Real life evaluation for the efficacy and safety of carnitine complex(GODEX) in liver enzyme elevated patients with metabolic disease

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0002209
• Lead Sponsor: Celltrion Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

common criteria

1) Over 19 years old (Adult)
2) From 1st January 2015 to 10th May 2016, patient who start to take carnitine complex combination therapy over 12 weeks
3) 40 IU/L = ALT = 400 IU/L (at index date)
4) The patients have medical recode for consecutive over 90 day before index date
5) From 60 days before index date, No change of dosage of medication for metabolic disease during taking carnitine complex

sub group

1. Type 2 DM : all common criteria is met.
1) Patients who are diagnosed with type 2 DM and take OPH over 90 days before index date
2) Before 60 days from index date, No change of dosage of OPH during taking carnitine complex

2. HTN : all common criteria is met.
1) Patients who are diagnosed with HTN and take antihypertensive over 90 days before index date
2) Before 60 days from index date, No change of dosage of antihypertensive during taking carnitine complex

3. Hyperlipidemia : all common criteria is met.
1) Patients who are diagnosed with Hyperlipidemia and take medication for Hyperlipidemia over 90 days before index date
2) Before 60 days from index date, No change of dosage of medication for Hyperlipidemia during taking carnitine complex

Exclusion Criteria

1) Under 19 years old
2) Chronic alcoholic disease
3) Acute hepatitis A
4) Chronic hepatitis B
5) Viral liver disease, alcoholic liver disesase, biliary obstruction, cirrhosis, drug induced liver disease
6) Type 1 DM or gestational diabetes or patient who is administered insulin.
7) Patients who take antiobestic drug before 30 days from index date

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of ALT, AST

Secondary Outcome Measures

Name	Time	Method
The change of body weight, BMI;Safety for Carnitine complex combination therapy;the change of indicator of metabolic diseases (type 2 DM, HTN, Hyperlipidemia)