NCT00234988

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

July 11, 2008

Conditions

Obesity

Keywords

SibutramineObesity

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    48 weeks

  • Safety parameters

    48 weeks

Secondary Outcomes (4)

  • Waist and hip circumference

    48 weeks

  • Fasting glucose

    48 weeks

  • Fasting lipids

    48 weeks

  • Uric acid

    48 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: sibutramine hydochloride monohydrate

Interventions

sibutramine hydochloride monohydrateDRUG

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

Also known as: ABT-991, sibutramine, Meridia
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information - Abbott

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Global Medical Information 1-800-633-9110

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

June 1, 2004

Primary Completion

January 1, 2006

Last Updated

July 15, 2008

Record last verified: 2008-07

Locations

US(1)