A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

NCT ID: NCT00234988

Last Updated: 2008-07-15

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.

Detailed Description

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Conditions

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Obesity

Keywords

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Sibutramine Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

sibutramine hydochloride monohydrate

Intervention Type DRUG

10 mg QD with the option to increase dose to 15 mg QD up until Week 4

Interventions

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sibutramine hydochloride monohydrate

10 mg QD with the option to increase dose to 15 mg QD up until Week 4

Intervention Type DRUG

Other Intervention Names

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ABT-991 sibutramine Meridia

Eligibility Criteria

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Inclusion Criteria

* Subject has nutritional obesity and BMI \>30 kg/m

Exclusion Criteria

* Type 1 or type 2 diabetes mellitus
* Inadequately controlled hypertension
* History of Gilles de la Tourette's Syndrome.
* Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids
* Hypothyroidism or hyperthyroidism.
* History of:

* benign prostatic hyperplasia
* neurological disorders
* psychiatric illness
* severe renal or hepatic impairments
* narrow-angle glaucoma
* History of cardiovascular disease or cerebrovascular disease
* Persistent tachycardia at rest
* Pulmonary hypertension
* Phaeochromocytoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information 1-800-633-9110

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information - Abbott

North Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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THAI-03-002

Identifier Type: -

Identifier Source: org_study_id