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Sibutramine for Olanzapine-Associated Weight Gain
NCT00044187Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2001
- Countries
- 1
- Sponsor
- Eli Lilly and Company
- Modality
- Small Molecules
- Drugs
- sibutramine
01
Overview
Phase 4, randomised, double-blind trial comparing Sibutramine + Olanzapine with Placebo + Olanzapine (2 arms). Primary endpoint: Change in Body Weight at 4 months. Started Apr 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sibutramine + Olanzapine
Sibutramine administered in combination with ongoing Olanzapine therapy.
Placebo + Olanzapine
Placebo administered in combination with ongoing Olanzapine therapy.
03
Who it enrols
Patients 18-65 years old diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and taking olanzapine. Excludes patients with uncontrolled high blood pressure, congestive heart failure, stroke, serious medical illness, or recent remoxipride use.
04
Endpoints
Primary
Change in Body Weight
Secondary
Safety and Side Effects
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