Skip to main content
OpenTrials
Completed

NCT Number: NCT00234988

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Global Medical Information - Abbott

North Chicago, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sibutramine hydochloride monohydrate

Drug

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

Other names: ABT-991, sibutramine, Meridia

Primary outcomes

  1. Weight loss

    Time frame: 48 weeks

  2. Safety parameters

    Time frame: 48 weeks

Secondary outcomes

  1. Waist and hip circumference

    Time frame: 48 weeks

  2. Fasting glucose

    Time frame: 48 weeks

  3. Fasting lipids

    Time frame: 48 weeks

  4. Uric acid

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Oct 10, 2005
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.