Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01872182
First received: May 30, 2013
Last updated: March 7, 2014
Last verified: March 2014

May 30, 2013
March 7, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
Percent change from baseline to 12 week in visceral fat area measured by CT [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01872182 on ClinicalTrials.gov Archive Site
  • improvement of metabolic profile [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
  • change of insulin resistance [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
  • change of BMI [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome

The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Abdominal Obesity Metabolic Syndrome
  • Drug: ALS-L1023
    daily twice for 12 weeks
  • Drug: placebo
    daily twice for 12 weeks
  • Experimental: Test arm
    ALS-L1023 300mg in two tablets
    Intervention: Drug: ALS-L1023
  • Placebo Comparator: Comparator arm
    placebo in two tablets
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Alcohol or any drug abuse
  • Any investigational medication during the preceding 3 months
Both
20 Years to 64 Years
No
Contact: Inseung Shin inseungshin@hanmi.co.kr
Korea, Republic of
 
NCT01872182
HM-MELS-301
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Hye Soon Park, M.D., Ph.D., M.P.H. Asan Medical Center
Hanmi Pharmaceutical Company Limited
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP