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A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00796367
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : August 31, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: VI-0521
Drug: Placebo
Enrollment 676
Recruitment Details Subjects were from OB-303 (NCT00553787)
Pre-assignment Details  
Arm/Group Title Placebo VI-0521 Mid VI-0521 Top
Hide Arm/Group Description Placebo VI-0521 7.5 mg PHEN/46 mg TPM VI-0521 15 mg PHEN/92 mg TPM
Period Title: Overall Study
Started 227 154 [1] 295
Completed 197 129 248
Not Completed 30 25 47
Reason Not Completed
Adverse Event             6             4             7
Lost to Follow-up             5             4             21
Withdrawal by Subject             9             11             12
Lack of Efficacy             2             1             0
non compliance             3             1             1
Pregnancy             1             0             1
Requirement for restricted medication             2             0             2
other             2             4             3
[1]
one participant signed ICF but withdrew from study prior to first dosing in OB-305
Arm/Group Title Placebo VI-0521 Mid VI-0521 Top Total
Hide Arm/Group Description Placebo VI-0521 7.5 mg PHEN/46 mg TPM VI-0521 15 mg PHEN/92 mg TPM Total of all reporting groups
Overall Number of Baseline Participants 227 153 295 675
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 227 participants 153 participants 295 participants 675 participants
52.7  (9.8) 52.2  (10.6) 51.2  (10.4) 51.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 153 participants 295 participants 675 participants
Female
147
  64.8%
106
  69.3%
195
  66.1%
448
  66.4%
Male
80
  35.2%
47
  30.7%
100
  33.9%
227
  33.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 227 participants 153 participants 295 participants 675 participants
227 153 295 675
1.Primary Outcome
Title Percent Weight Change at End of Treatment, Week 108.
Hide Description [Not Specified]
Time Frame From baseline to end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Last observation carried forward (ITT-LOCF)
Arm/Group Title Placebo VI-0521 Mid VI-0521 Top
Hide Arm/Group Description:
Placebo
VI-0521 7.5 mg phentermine/46 mg topiramate
VI-0521 15 mg phentermine/92 mg topiramate
Overall Number of Participants Analyzed 227 153 295
Least Squares Mean (Standard Error)
Unit of Measure: percent weight loss
-1.8  (0.55) -9.32  (0.67) -10.5  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Top
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
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 8.71
Confidence Interval (2-Sided) 95%
7.39 to 10.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.673
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Mid
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
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 7.52
Confidence Interval (2-Sided) 95%
5.95 to 9.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.799
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI-0521 Mid, VI-0521 Top
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1189
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 1.19
Confidence Interval (2-Sided) 95%
-0.31 to 2.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.760
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Hide Description [Not Specified]
Time Frame Baseline to End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
Arm/Group Title Placebo VI-0521 Mid VI-0521 Top
Hide Arm/Group Description:
Placebo
VI-0521 7.5 mg phentermine/46 mg topiramate
VI-0521 15 mg phentermine/92 mg topiramate
Overall Number of Participants Analyzed 227 153 295
Measure Type: Number
Unit of Measure: percent participants
30 75.2 79.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Top
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
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 9.4
Confidence Interval (2-Sided) 95%
6.24 to 14.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VI-0521 Mid
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
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 6.99
Confidence Interval (2-Sided) 95%
4.36 to 11.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI-0521 Mid, VI-0521 Top
Comments No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2169
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.84 to 2.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
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 [Not Specified]
 
Arm/Group Title Placebo VI-0521 Mid VI-0521 Top
Hide Arm/Group Description Placebo VI-0521 7.5 mg PHEN/46 mg TPM VI-0521 15 mg PHEN/92 mg TPM
All-Cause Mortality
Placebo VI-0521 Mid VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo VI-0521 Mid VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/227 (3.96%)   4/153 (2.61%)   13/295 (4.41%) 
Cardiac disorders       
myocardial infarction  1  0/227 (0.00%)  1/153 (0.65%)  0/295 (0.00%) 
acute myocardial infarction  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Gastrointestinal disorders       
peptic ulcer hemorrhage  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
inguinal hernia, obstructive  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
abdominal hernia  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
General disorders       
serositis  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Hepatobiliary disorders       
cholecystitis  1  0/227 (0.00%)  1/153 (0.65%)  0/295 (0.00%) 
acute cholecystitis  1  0/227 (0.00%)  1/153 (0.65%)  0/295 (0.00%) 
cholelithiasis  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Immune system disorders       
drug hypersensitivity  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Infections and infestations       
pneumonia  1  1/227 (0.44%)  0/153 (0.00%)  1/295 (0.34%) 
appendicitis  1  1/227 (0.44%)  0/153 (0.00%)  2/295 (0.68%) 
pyelonephritis  1  0/227 (0.00%)  1/153 (0.65%)  0/295 (0.00%) 
influenza  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Injury, poisoning and procedural complications       
ankle fracture  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
humerus fracture  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Musculoskeletal and connective tissue disorders       
arthralgia  1  1/227 (0.44%)  0/153 (0.00%)  1/295 (0.34%) 
osteoarthritis  1  0/227 (0.00%)  0/153 (0.00%)  2/295 (0.68%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
mesothelioma  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Nervous system disorders       
hemorrhage intracranial  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
transient ischemic attack  1  0/227 (0.00%)  1/153 (0.65%)  0/295 (0.00%) 
cerebrovascular accident  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
ischemic stroke  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Psychiatric disorders       
depression  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Renal and urinary disorders       
nephritic syndrome  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
renal failure, acute  1  0/227 (0.00%)  0/153 (0.00%)  2/295 (0.68%) 
Reproductive system and breast disorders       
uterine prolapse  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
benign prostatic hyperplasia  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
cervical dysplasia  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Respiratory, thoracic and mediastinal disorders       
respiratory failure  1  0/227 (0.00%)  0/153 (0.00%)  1/295 (0.34%) 
Vascular disorders       
hypotension  1  1/227 (0.44%)  0/153 (0.00%)  0/295 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo VI-0521 Mid VI-0521 Top
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   182/227 (80.18%)   111/153 (72.55%)   234/295 (79.32%) 
Eye disorders       
eye pain  1  2/227 (0.88%)  4/153 (2.61%)  4/295 (1.36%) 
Gastrointestinal disorders       
constipation  1  7/227 (3.08%)  11/153 (7.19%)  12/295 (4.07%) 
nausea  1  4/227 (1.76%)  10/153 (6.54%)  4/295 (1.36%) 
diarrhea  1  3/227 (1.32%)  3/153 (1.96%)  11/295 (3.73%) 
tooth ache  1  5/227 (2.20%)  4/153 (2.61%)  2/295 (0.68%) 
abdominal pain  1  5/227 (2.20%)  0/153 (0.00%)  3/295 (1.02%) 
hemorrhoids  1  1/227 (0.44%)  1/153 (0.65%)  6/295 (2.03%) 
vomiting  1  2/227 (0.88%)  4/153 (2.61%)  1/295 (0.34%) 
abdominal discomfort  1  0/227 (0.00%)  3/153 (1.96%)  0/295 (0.00%) 
General disorders       
edema peripheral  1  7/227 (3.08%)  0/153 (0.00%)  12/295 (4.07%) 
Immune system disorders       
seasonal allergy  1  2/227 (0.88%)  3/153 (1.96%)  6/295 (2.03%) 
Infections and infestations       
upper respiratory tract infection  1  42/227 (18.50%)  26/153 (16.99%)  45/295 (15.25%) 
nasopharyngitis  1  26/227 (11.45%)  13/153 (8.50%)  26/295 (8.81%) 
sinusitis  1  18/227 (7.93%)  12/153 (7.84%)  28/295 (9.49%) 
urinary tract infection  1  13/227 (5.73%)  14/153 (9.15%)  18/295 (6.10%) 
influenza  1  8/227 (3.52%)  10/153 (6.54%)  19/295 (6.44%) 
bronchitis  1  7/227 (3.08%)  8/153 (5.23%)  10/295 (3.39%) 
Gastroenteritis  1  6/227 (2.64%)  2/153 (1.31%)  9/295 (3.05%) 
gastroenteritis viral  1  6/227 (2.64%)  4/153 (2.61%)  4/295 (1.36%) 
ear infection  1  2/227 (0.88%)  3/153 (1.96%)  7/295 (2.37%) 
tooth abscess  1  4/227 (1.76%)  4/153 (2.61%)  4/295 (1.36%) 
pneumonia  1  4/227 (1.76%)  4/153 (2.61%)  3/295 (1.02%) 
viral infection  1  3/227 (1.32%)  2/153 (1.31%)  6/295 (2.03%) 
tooth infection  1  1/227 (0.44%)  3/153 (1.96%)  4/295 (1.36%) 
oral herpes  1  2/227 (0.88%)  3/153 (1.96%)  2/295 (0.68%) 
Injury, poisoning and procedural complications       
procedural pain  1  4/227 (1.76%)  8/153 (5.23%)  14/295 (4.75%) 
joint sprain  1  4/227 (1.76%)  5/153 (3.27%)  7/295 (2.37%) 
muscle strain  1  4/227 (1.76%)  6/153 (3.92%)  6/295 (2.03%) 
contusion  1  2/227 (0.88%)  3/153 (1.96%)  7/295 (2.37%) 
Investigations       
weight increased  1  5/227 (2.20%)  0/153 (0.00%)  7/295 (2.37%) 
hemoglobin decreased  1  2/227 (0.88%)  3/153 (1.96%)  0/295 (0.00%) 
abdominal bruit  1  0/227 (0.00%)  3/153 (1.96%)  1/295 (0.34%) 
Metabolism and nutrition disorders       
diabetes mellitus  1  7/227 (3.08%)  1/153 (0.65%)  3/295 (1.02%) 
dyslipidemia  1  6/227 (2.64%)  2/153 (1.31%)  0/295 (0.00%) 
Musculoskeletal and connective tissue disorders       
arthralgia  1  14/227 (6.17%)  7/153 (4.58%)  16/295 (5.42%) 
back pain  1  7/227 (3.08%)  9/153 (5.88%)  15/295 (5.08%) 
musculoskeletal pain  1  11/227 (4.85%)  4/153 (2.61%)  6/295 (2.03%) 
pain in extremity  1  11/227 (4.85%)  3/153 (1.96%)  5/295 (1.69%) 
osteoarthritis  1  5/227 (2.20%)  4/153 (2.61%)  7/295 (2.37%) 
muscle spasms  1  5/227 (2.20%)  4/153 (2.61%)  6/295 (2.03%) 
myalgia  1  2/227 (0.88%)  3/153 (1.96%)  6/295 (2.03%) 
Nervous system disorders       
headache  1  6/227 (2.64%)  4/153 (2.61%)  12/295 (4.07%) 
paresthesia  1  0/227 (0.00%)  1/153 (0.65%)  10/295 (3.39%) 
Psychiatric disorders       
insomnia  1  8/227 (3.52%)  9/153 (5.88%)  11/295 (3.73%) 
depression  1  2/227 (0.88%)  3/153 (1.96%)  10/295 (3.39%) 
anxiety  1  3/227 (1.32%)  3/153 (1.96%)  6/295 (2.03%) 
Respiratory, thoracic and mediastinal disorders       
cough  1  4/227 (1.76%)  4/153 (2.61%)  10/295 (3.39%) 
pharyngolaryngeal pain  1  6/227 (2.64%)  3/153 (1.96%)  8/295 (2.71%) 
sinus congestion  1  6/227 (2.64%)  4/153 (2.61%)  3/295 (1.02%) 
Vascular disorders       
hypertension  1  9/227 (3.96%)  2/153 (1.31%)  10/295 (3.39%) 
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
Layout table for Results Point of Contact information
Name/Title: Wesley W Day, PhD
Organization: Vivus, Inc
Phone: 650.934.5200
EMail: day@vivus.com
Layout table for additonal information
Responsible Party: VIVUS LLC
ClinicalTrials.gov Identifier: NCT00796367    
Other Study ID Numbers: OB-305
First Submitted: November 20, 2008
First Posted: November 24, 2008
Results First Submitted: July 31, 2012
Results First Posted: August 31, 2012
Last Update Posted: September 10, 2012