Status:
TERMINATED
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Abdominal Obesity Metabolic Syndrome
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.
Eligibility Criteria
Inclusion
- Aged between 20 and 64 years(Both genders)
- more than 2 among components of the metabolic syndrome
- Triglyceride \>= 150mg/dL
- HDL-D: Women \< 50mg/dL or Men \< 40mg/dL
- Hypertension: Systolic blood pressure \>= 130mmHg or Diastolic blood pressure \>= 85mmHg
- Hyperglycemia: fasting plasma glucose \>= 100 mg/dL
- Informed consent awarding
Exclusion
- Alcohol or any drug abuse
- Any investigational medication during the preceding 3 months
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01872182
Start Date
May 1 2013
End Date
January 1 2015
Last Update
October 11 2016
Active Locations (1)
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1
5 Institutions
Seoul, South Korea