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NCT01184560

A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Study to Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Completed NA Last updated 18 August 2010
What this trial tests

NA trial testing Sibutramine in Obesity in 174 participants. Completed in 1 July 2010.

Timeline
1 February 2010
Primary endpoint
1 July 2010
1 July 2010

Quick facts

Lead sponsorGachon University Gil Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment174
Start date1 February 2010
Primary completion1 July 2010
Estimated completion1 July 2010
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Gachon University Gil Medical Center

Who can join

Adults 18 to 50, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze. * Study phase: Investigator-initiated clinical study (Pilot study) * Method of blinding: Double-blind * Control: Placebo-controlled * Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1) * Studied disease: Obesity * Study population: Subjects eligible for inclusion/exclusion criteria * Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of the G-protein β3 subunit 825T allele on the change of body adiposity in obese female.
    Hwang IC, Kim KK, Ahn HY, Suh HS, et al · · 2013 · cited 11× · PMID 23061407 · DOI 10.1111/dom.12023

Verify or expand the search:

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Gachon University Gil Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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