Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00554216
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, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: VI-0521
Drug: Placebo matched phentermine/topiramate

  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 Low PHEN/TPM 3.75 mg/23 mg
VI-0521 Top PHEN/TPM 15 mg/92 mg

Participant Flow:   Overall Study
    Placebo     VI-0521 Low     VI-0521 Top  
STARTED     514     241     512  
COMPLETED     272     147     340  
NOT COMPLETED     242     94     172  
Lost to Follow-up                 92                 31                 63  
Adverse Event                 16                 16                 36  
Withdrawal by Subject                 92                 31                 43  
Non compliance                 10                 4                 5  
Pregnancy                 2                 1                 14  
Restricted med                 3                 1                 1  
not specified                 12                 7                 10  
Lack of Efficacy                 15                 3                 0  



  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 Low PHEN/TPM 3.75/23
VI-0521 Top PHEN/TPM 15/92
Total Total of all reporting groups

Baseline Measures
    Placebo     VI-0521 Low     VI-0521 Top     Total  
Number of Participants  
[units: participants]
  514     241     512     1267  
Age  
[units: years]
Mean ± Standard Deviation
  43.0  ± 11.76     43.0  ± 10.96     42.0  ± 12.21     42.6  ± 11.80  
Gender  
[units: participants]
       
Female     425     201     424     1050  
Male     89     40     88     217  
Region of Enrollment  
[units: participants]
       
United States     514     241     512     1267  



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

2.  Primary:   Percentage of Subjects With at Least 5% Weight Loss at Week 56   [ 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


Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00554216     History of Changes
Other Study ID Numbers: OB-302
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