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

Abbott

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: sibutramine hydochloride monohydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234988

THAI-03-002

Details and patient eligibility

About

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

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

93 participants in 1 patient group

1

Experimental group

Treatment:

Drug: sibutramine hydochloride monohydrate