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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VI-0521 Low | Experimental | VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) |
|
| VI-0521 Top | Experimental | Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. |
|
| Placebo | Placebo Comparator | Placebo to match |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 | Drug | 3.75 mg phentermine/23 mg topiramate |
| |
| VI-0521 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Loss From Baseline to Week 56 | baseline to 56 weeks | |
| Percentage of Subjects With at Least 5% Weight Loss at Week 56 | baseline to 56 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Peterson | VIVUS LLC | Study Director |
| Kishore Gadde, MD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | 92130 | United States | ||
| Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28455281 | Derived | Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28. |
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Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | VI-0521 Low | PHEN/TPM 3.75 mg/23 mg |
| FG002 | VI-0521 Top | PHEN/TPM 15 mg/92 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | VI-0521 Low | PHEN/TPM 3.75/23 |
| BG002 | VI-0521 Top |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Weight Loss From Baseline to Week 56 | intent-to-treat last-observation-carried-forward (ITT-LOCF) | Posted | Least Squares Mean | Standard Error | percent weight loss | baseline to 56 weeks |
|
AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wesley W. Day PhD | Vivus, Inc. | 650-934-5200 | day@vivus.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Drug |
15 mg phentermine/92 mg topiramate |
|
| Placebo matched phentermine/topiramate | Drug | Placebo matched phentermine/topiramate |
|
| Ridgefield |
| Connecticut |
| 06877 |
| United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Toledo | Ohio | 43623 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Withdrawal by Subject |
|
| Non compliance |
|
| Pregnancy |
|
| Restricted med |
|
| Other |
|
| Lack of Efficacy |
|
PHEN/TPM 15/92 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Percentage of Subjects With at Least 5% Weight Loss at Week 56 | intent-to-treat last-observation-carried-forward (ITT-LOCF) | Posted | Number | percentage of participants | baseline to 56 weeks |
|
|
|
|
| 14 |
| 513 |
| 374 |
| 513 |
| EG001 | VI-0521 Low | PHEN/TPM 3.75/23 | 6 | 240 | 192 | 240 |
| EG002 | VI-0521 Top | PHEN/TPM 15/92 | 13 | 511 | 432 | 511 |
| Uterine Proplapse | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| pancreatitus | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| uterine polyp | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA (10.1) | Systematic Assessment |
|
| angina pectoris | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| thrombophlebitis superficial | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| hypersensitivity | Immune system disorders | MedDRA (10.1) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
|
| abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (10.1) | Systematic Assessment |
|
| abdominal wall abscess | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
|
| staphylococcal infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| paresthesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| vision blurred | Eye disorders | MedDRA (10.1) | Systematic Assessment |
|
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.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Carbohydrates |
| D007661 | Ketoses |
| 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. | Regression, Logistic | <0.0001 | Intersection-union method applied in a step-down testing approach | Odds Ratio (OR) | 3.97 | Standard Error of the Mean | 0.706 | 2-Sided | 95 | 2.80 | 5.63 | No | Superiority or Other |
| 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. | Regression, Logistic | <0.0001 | Intersection-union method applied in a step-down testing approach | Odds Ratio (OR) | 2.42 | Standard Error of the Mean | 0.394 | 2-Sided | 95 | 1.76 | 3.33 | No | Superiority or Other |