A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00645190|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Galantamine HBr||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double Blind, Active Control, Flexible Dose, Multicenter Study to Evaluate Galantamine HBr in the Treatment of Alzheimer's Disease:Safety and Effectiveness of an Immediate-release Table Formulation.|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||February 2005|
- Primary endpoint (ADAS-cog/11) decreased 5.4 ± 6.4 and 4 .0 ± 7.3 in galantamine and Donepezil group respectively after 16-week treatment from baseline of 22.5 ± 9.3 and 23.3 ± 9.7 respectively, showing the non-inferiority in term of efficacy.
- Secondary endpoint is responder rate. It showed 78% responder rate in galantamine group and 58% responder rate in Donepezil group after 16 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645190
|Study Director:||Xian-Janssen Pharmaceutical Ltd. Clinical Trial||Xian-Janssen Pharmaceutical Ltd.|