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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00600067 |
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Date of registration:
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11/01/2008 |
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Primary sponsor: |
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Public title:
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A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
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Scientific title:
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A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00600067 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Barbara Troupin, MD, MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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VIVUS, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have completed the qualifying OB-202 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
Exclusion Criteria:
- Subjects who have developed one or more morbidities during the OB-202 trial that
would pose a safety concern
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Intervention(s)
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Drug: Phentermine/Topiramate
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Drug: Placebo
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Primary Outcome(s)
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HbA1c Change From Baseline Week 0 to Week 56
[Time Frame: Baseline to 56 weeks]
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Secondary Outcome(s)
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Percent Weight Loss From Baseline to Week 56
[Time Frame: Baseline to 56 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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