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

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ClinicalTrials.gov Identifier: NCT00554216
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : September 6, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: VI-0521
Drug: Placebo matched phentermine/topiramate
Enrollment 1267
Recruitment Details Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008
Pre-assignment Details  
Arm/Group Title Placebo VI-0521 Low VI-0521 Top
Hide Arm/Group Description [Not Specified] PHEN/TPM 3.75 mg/23 mg PHEN/TPM 15 mg/92 mg
Period Title: Overall Study
Started 514 241 512
Completed 272 147 340
Not Completed 242 94 172
Reason Not Completed
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
Arm/Group Title Placebo VI-0521 Low VI-0521 Top Total
Hide Arm/Group Description [Not Specified] PHEN/TPM 3.75/23 PHEN/TPM 15/92 Total of all reporting groups
Overall Number of Baseline Participants 514 241 512 1267
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 514 participants 241 participants 512 participants 1267 participants
43.0  (11.76) 43.0  (10.96) 42.0  (12.21) 42.6  (11.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 514 participants 241 participants 512 participants 1267 participants
Female
425
  82.7%
201
  83.4%
424
  82.8%
1050
  82.9%
Male
89
  17.3%
40
  16.6%
88
  17.2%
217
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 514 participants 241 participants 512 participants 1267 participants
514 241 512 1267
1.Primary Outcome
Title Percent Weight Loss From Baseline to Week 56
Hide Description [Not Specified]
Time Frame baseline to 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat last-observation-carried-forward (ITT-LOCF)
Arm/Group Title Placebo VI-0521 Low VI-0521 Top
Hide Arm/Group Description:
[Not Specified]
PHEN/TPM 3.75 mg/23 mg
PHEN/TPM 15 mg/92 mg
Overall Number of Participants Analyzed 498 234 498
Least Squares Mean (Standard Error)
Unit of Measure: percent weight loss
1.55  (0.395) 5.10  (0.538) 10.92  (0.392)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Top
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.36
Confidence Interval (2-Sided) 95%
8.43 to 10.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.476
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Low
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.54
Confidence Interval (2-Sided) 95%
2.38 to 4.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.596
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI-0521 Low, VI-0521 Top
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.82
Confidence Interval (2-Sided) 95%
4.65 to 6.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.596
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects With at Least 5% Weight Loss at Week 56
Hide Description [Not Specified]
Time Frame baseline to 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat last-observation-carried-forward (ITT-LOCF)
Arm/Group Title Placebo VI-0521 Low VI-0521 Top
Hide Arm/Group Description:
[Not Specified]
PHEN/TPM 3.75 mg/23 mg
PHEN/TPM 15 mg/92 mg
Overall Number of Participants Analyzed 498 234 498
Measure Type: Number
Unit of Measure: percentage of participants
17.3 44.9 66.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Top
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.61
Confidence Interval (2-Sided) 95%
7.13 to 12.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.463
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Low
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
2.80 to 5.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.706
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI-0521 Low, VI-0521 Top
Comments With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Intersection-union method applied in a step-down testing approach
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.42
Confidence Interval (2-Sided) 95%
1.76 to 3.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.394
Estimation Comments [Not Specified]
Time Frame AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Adverse Event Reporting Description Only subjects who received at least one dose of study drug were included in the safety analysis.
 
Arm/Group Title Placebo VI-0521 Low VI-0521 Top
Hide Arm/Group Description [Not Specified] PHEN/TPM 3.75/23 PHEN/TPM 15/92
All-Cause Mortality
Placebo VI-0521 Low VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo VI-0521 Low VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/513 (2.73%)   6/240 (2.50%)   13/511 (2.54%) 
Cardiac disorders       
angina pectoris  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
myocardial infarction  1  0/513 (0.00%)  1/240 (0.42%)  0/511 (0.00%) 
atrial fibrillation  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Ear and labyrinth disorders       
Meniere's disease  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Gastrointestinal disorders       
pancreatitus  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
General disorders       
Chest Pain  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  3/513 (0.58%)  1/240 (0.42%)  1/511 (0.20%) 
Cholangitis  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Immune system disorders       
hypersensitivity  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Infections and infestations       
cellulitis  1  0/513 (0.00%)  1/240 (0.42%)  0/511 (0.00%) 
appendicitis  1  0/513 (0.00%)  1/240 (0.42%)  0/511 (0.00%) 
abdominal wall abscess  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
staphylococcal infection  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Metabolism and nutrition disorders       
electrolyte imbalance  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Musculoskeletal and connective tissue disorders       
spinal osteoarthritis  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
prostate cancer  1  2/513 (0.39%)  0/240 (0.00%)  0/511 (0.00%) 
metastatic neoplasm  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
breast cancer  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
myeloid leukemia  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Pregnancy, puerperium and perinatal conditions       
abortion missed  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Psychiatric disorders       
suicidal ideation  1  0/513 (0.00%)  0/240 (0.00%)  1/511 (0.20%) 
Renal and urinary disorders       
hematuria  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Reproductive system and breast disorders       
Uterine Proplapse  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
uterine polyp  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
pulmonary embolism  1  1/513 (0.19%)  0/240 (0.00%)  1/511 (0.20%) 
Vascular disorders       
hypertension  1  1/513 (0.19%)  0/240 (0.00%)  0/511 (0.00%) 
deep vein thrombosis  1  0/513 (0.00%)  1/240 (0.42%)  1/511 (0.20%) 
thrombophlebitis superficial  1  0/513 (0.00%)  1/240 (0.42%)  0/511 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo VI-0521 Low VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   374/513 (72.90%)   192/240 (80.00%)   432/511 (84.54%) 
Eye disorders       
vision blurred  1  16/513 (3.12%)  15/240 (6.25%)  23/511 (4.50%) 
Gastrointestinal disorders       
constipation  1  35/513 (6.82%)  19/240 (7.92%)  72/511 (14.09%) 
dry mouth  1  19/513 (3.70%)  16/240 (6.67%)  87/511 (17.03%) 
nausea  1  24/513 (4.68%)  14/240 (5.83%)  37/511 (7.24%) 
diarrhea  1  23/513 (4.48%)  12/240 (5.00%)  24/511 (4.70%) 
General disorders       
fatigue  1  17/513 (3.31%)  12/240 (5.00%)  23/511 (4.50%) 
Infections and infestations       
upper respiratory tract infection  1  56/513 (10.92%)  38/240 (15.83%)  63/511 (12.33%) 
nasopharyngitis  1  37/513 (7.21%)  30/240 (12.50%)  46/511 (9.00%) 
sinusitis  1  28/513 (5.46%)  18/240 (7.50%)  37/511 (7.24%) 
influenza  1  24/513 (4.68%)  18/240 (7.50%)  26/511 (5.09%) 
bronchitis  1  22/513 (4.29%)  16/240 (6.67%)  28/511 (5.48%) 
Musculoskeletal and connective tissue disorders       
back pain  1  26/513 (5.07%)  13/240 (5.42%)  28/511 (5.48%) 
Nervous system disorders       
headache  1  52/513 (10.14%)  25/240 (10.42%)  61/511 (11.94%) 
paresthesia  1  10/513 (1.95%)  10/240 (4.17%)  96/511 (18.79%) 
dizziness  1  21/513 (4.09%)  7/240 (2.92%)  29/511 (5.68%) 
dysgeusia  1  5/513 (0.97%)  3/240 (1.25%)  43/511 (8.41%) 
Psychiatric disorders       
insomnia  1  25/513 (4.87%)  12/240 (5.00%)  40/511 (7.83%) 
Respiratory, thoracic and mediastinal disorders       
cough  1  18/513 (3.51%)  8/240 (3.33%)  26/511 (5.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.
After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
Results Point of Contact
Name/Title: Wesley W. Day PhD
Organization: Vivus, Inc.
Phone: 650-934-5200
EMail: day@vivus.com
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00554216     History of Changes
Other Study ID Numbers: OB-302
First Submitted: November 3, 2007
First Posted: November 6, 2007
Results First Submitted: July 31, 2012
Results First Posted: September 6, 2012
Last Update Posted: September 10, 2012