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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Abdominal Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test arm

ALS-L1023 300mg in two tablets

Group Type EXPERIMENTAL

ALS-L1023

Intervention Type DRUG

daily twice for 12 weeks

Comparator arm

placebo in two tablets

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

daily twice for 12 weeks

Interventions

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ALS-L1023

daily twice for 12 weeks

Intervention Type DRUG

placebo

daily twice for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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