Efficacy and Safety Study of ALS-L1023 in Patients With A... | NCT01872182

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

NCT01872182

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Terminated

Last Update Posted

Oct 11, 2016Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Abdominal Obesity Metabolic Syndrome

Interventions

ALS-L1023
placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

Jun 3, 2013

First Posted Date

Jun 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test arm	Experimental	ALS-L1023 300mg in two tablets	Drug: ALS-L1023
Comparator arm	Placebo Comparator	placebo in two tablets	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALS-L1023	Drug	daily twice for 12 weeks	Test arm
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from baseline to 12 week in visceral fat area measured by CT		baseline and 12 week

Secondary Outcomes

Measure	Description	Time Frame
improvement of metabolic profile		baseline and 12 week
change of insulin resistance		baseline and 12 week
change of BMI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hye Soon Park, M.D., Ph.D., M.P.H.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
5 Institutions		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
C535554	Abdominal obesity metabolic syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000608553	ALS-L1023

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided