Status:
COMPLETED
Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chr...
Detailed Description
This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from patients who were randomized (assigned...
Eligibility Criteria
Inclusion
- Must have been randomized within the previous topiramate obesity and diabetes studies: PRI/TOP-INT-31 or PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study
- Must consent to participate and use data from previous clinical trials in connection with results from the genetic analyses
Exclusion
- Patients who received a blood transfusion within 60 days before collecting DNA samples
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
1145 Patients enrolled
Trial Details
Trial ID
NCT00304603
Start Date
April 1 2004
End Date
April 1 2005
Last Update
November 28 2012
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