Status:
TERMINATED
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Lead Sponsor:
VIVUS LLC
Collaborating Sponsors:
Synteract, Inc.
Sentrx
Conditions:
Diabetes
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in contr...
Eligibility Criteria
Inclusion
- Have completed the qualifying DM-230 trial
- If females of child-bearing potential, subjects must be using adequate contraception
- Provide written informed consent
- Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
- Be greater than 80% compliant in study medication use during the last three visits for DM-230
Exclusion
- Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00737633
Start Date
August 1 2008
End Date
June 1 2009
Last Update
September 10 2012
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
San Francisco, California, United States
4
Research Site
Spring Valley, California, United States