Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00553787
First received: November 3, 2007
Last updated: September 5, 2012
Last verified: September 2012
Results First Received: July 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Type 2 Diabetes
Intervention: Drug: VI-0521

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo No text entered.
VI-0521 Mid 7.5 mg/46 mg phentermine/topiramate
VI-0521 Top 15 mg/92 mg phentermine/topiramate

Participant Flow:   Overall Study
    Placebo     VI-0521 Mid     VI-0521 Top  
STARTED     994     498     995  
COMPLETED     616     374     733  
NOT COMPLETED     378     124     262  
Adverse Event                 34                 21                 67  
Lost to Follow-up                 132                 44                 78  
Withdrawal by Subject                 151                 40                 83  
Lack of Efficacy                 31                 1                 3  
Pregnancy                 0                 1                 2  
non compliance                 4                 0                 11  
Requirement for restricted medication                 8                 7                 5  
not specified                 18                 10                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
VI-0521 Mid 7.5 mg/46 mg phentermine/topiramate
VI-0521 Top 15 mg/92 mg phentermine/topiramate
Total Total of all reporting groups

Baseline Measures
    Placebo     VI-0521 Mid     VI-0521 Top     Total  
Number of Participants  
[units: participants]
  994     498     995     2487  
Age  
[units: years]
Mean ± Standard Deviation
  51.2  ± 10.3     51.1  ± 10.4     51  ± 10.7     51.1  ± 10.4  
Gender  
[units: participants]
       
Female     695     349     693     1737  
Male     299     149     302     750  
Region of Enrollment  
[units: participants]
       
United States     994     498     995     2487  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Weight Loss From Baseline to Week 56   [ Time Frame: Baseline to 56 weeks ]

2.  Primary:   Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF   [ Time Frame: Baseline to 56 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Wesley W Day PhD
Organization: Vivus, Inc
phone: 650-934-5200
e-mail: day@vivus.com


No publications provided by VIVUS, Inc.

Publications automatically indexed to this study:

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00553787     History of Changes
Other Study ID Numbers: OB-303
Study First Received: November 3, 2007
Results First Received: July 31, 2012
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration