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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01872182
First received: May 30, 2013
Last updated: October 10, 2016
Last verified: October 2016
May 30, 2013
October 10, 2016
May 2013
January 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 ]
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 ]
  • change of insulin resistance [ Time Frame: baseline and 12 week ]
  • change of BMI [ Time Frame: baseline and 12 week ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Terminated
200
January 2015
January 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
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01872182
HM-MELS-301
No
Not Provided
Not Provided
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
October 2016

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