A Phase IV, Multi-Center, Open-Label Trial of Sibutramine... | NCT00234988

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

NCT00234988

Sponsor

Abbott

Status

Completed

Last Update Posted

Jul 15, 2008Estimated

Enrollment

93Actual

Phase

Phase 4

Conditions

Obesity

Interventions

sibutramine hydochloride monohydrate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jan 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2008

Last Update Posted Date

Jul 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: sibutramine hydochloride monohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sibutramine hydochloride monohydrate	Drug	10 mg QD with the option to increase dose to 15 mg QD up until Week 4	1

Measure	Description	Time Frame
Weight loss		48 weeks
Safety parameters		48 weeks

Measure	Description	Time Frame
Waist and hip circumference		48 weeks
Fasting glucose		48 weeks
Fasting lipids

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Medical Information 1-800-633-9110	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Global Medical Information - Abbott		North Chicago	Illinois	60064	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided