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CompletedNCT00234988Updated Jul 15, 2008

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

A Phase 4 interventional study of sibutramine hydochloride monohydrate in Obesity, sponsored by Abbott. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-07-15.

Sponsored by Abbott · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
93
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity

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Keywords

  • Sibutramine
  • Obesity
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 93 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    1

    Drug: sibutramine hydochloride monohydrate

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Global Medical Information - Abbott
    North Chicago, Illinois 60064, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2004 and a primary completion of Jan 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2005
First posted
Oct 10, 2005
Start
Jun 2004
Primary completionActual
Jan 2006
Last update
Jul 15, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00234988
Lead sponsor
Abbott
First posted
Oct 10, 2005
Start date
Jun 2004
Primary completion
Jan 2006
Last update
Jul 15, 2008

Study contacts

Global Medical Information 1-800-633-9110
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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