MedPath

Sibutramine

Generic Name
Sibutramine
Drug Type
Small Molecule
Chemical Formula
C17H26ClN
CAS Number
106650-56-0
Unique Ingredient Identifier
WV5EC51866
Background

Sibutramine (trade name Meridia in the USA, Reductil in Europe and other countries), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally acting stimulant chemically related to amphetamines thus it is classified as a Schedule IV controlled substance in the United States. In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.

Indication

For the treatment of obesity.

Associated Conditions
Obesity

A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects

Phase 1
Completed
Conditions
Obesity
Interventions
Other: sibutramine placebo
First Posted Date
2012-05-14
Last Posted Date
2017-06-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
60
Registration Number
NCT01597609
Locations
🇬🇧

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

Phase 4
Conditions
Obesity
Polycystic Ovaries Syndrome
Interventions
Behavioral: Diet and physical exercise
First Posted Date
2011-11-21
Last Posted Date
2011-11-21
Lead Sponsor
Aristotle University Of Thessaloniki
Target Recruit Count
200
Registration Number
NCT01475019
Locations
🇬🇷

Aristotle University of Thessaloniki Medical School, Thessaloniki, Greece

Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Not Applicable
Completed
Conditions
Obesity
Interventions
First Posted Date
2010-08-19
Last Posted Date
2010-08-19
Lead Sponsor
Gachon University Gil Medical Center
Target Recruit Count
174
Registration Number
NCT01184560
Locations
🇰🇷

GachonGill Medical Center, Inchon, Namdong-gu, Korea, Republic of

Studying the Effects of Sibutramine on Eating Behavior

Phase 4
Terminated
Conditions
Obesity
Interventions
Drug: Placebo
First Posted Date
2010-07-27
Last Posted Date
2017-08-30
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
14
Registration Number
NCT01170364
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

A Weight Loss Study in Overweight Men and Women

Phase 2
Terminated
Conditions
Obesity
Interventions
First Posted Date
2009-10-12
Last Posted Date
2011-06-03
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
343
Registration Number
NCT00993421
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Richmond, Virginia, United States

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Phase 3
Conditions
Obesity
Interventions
Drug: Sibutramine-Metformin
First Posted Date
2009-07-17
Last Posted Date
2009-07-17
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
60
Registration Number
NCT00941382
Locations
🇲🇽

Centro Universitario de Ciencias de la Salud, Guadalajara, Jalisco, Mexico

A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)

Phase 1
Completed
Conditions
Obesity
Interventions
Drug: Placebo
First Posted Date
2009-06-04
Last Posted Date
2015-10-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
15
Registration Number
NCT00914212

Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

Phase 4
Completed
Conditions
Obstructive Sleep Apnea
Obesity
Hypertension
Interventions
Device: CPAP
First Posted Date
2008-08-08
Last Posted Date
2013-04-11
Lead Sponsor
Laval University
Target Recruit Count
45
Registration Number
NCT00729963

Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

Phase 3
Completed
Conditions
Obesity
Hypertension
Interventions
Drug: verapamil/trandolapril
Drug: metoprolol/HCT
First Posted Date
2008-05-19
Last Posted Date
2008-05-19
Lead Sponsor
Abbott
Target Recruit Count
171
Registration Number
NCT00679653

Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population

Phase 3
Completed
Conditions
Obesity
Interventions
Drug: Placebo
First Posted Date
2008-05-14
Last Posted Date
2008-05-14
Lead Sponsor
Abbott
Target Recruit Count
103
Registration Number
NCT00677391
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