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

Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234988

Enrollment

Registered

2005-10-10

Start date

2004-06-30

Completion date

Unknown

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Sibutramine, Obesity

Brief summary

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

Interventions

DRUGsibutramine hydochloride monohydrate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Weight loss	48 weeks
Safety parameters	48 weeks

Secondary

Measure	Time frame
Waist and hip circumference	48 weeks
Fasting glucose	48 weeks
Fasting lipids	48 weeks
Uric acid	48 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026