Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Synteract, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Phentermine 15mg/topiramate 100mg |
|
| 2 | Placebo Comparator | Matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 | Drug | phentermine 15mg/topiramate 100mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 28. | Baseline to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Weight Change (kg) From Baseline to Week 28 | Baseline to 28 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara Troupin, MD, MBA | VIVUS LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
Not provided
Subject recruitment occurred in 10 investigative sites in the U.S. between May 2007 and July 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active | Phentermine 15mg/topiramate 100mg |
| FG001 | Placebo | Matched placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active | Phentermine 15mg/topiramate 100mg |
| BG001 | Placebo | Matched placebo |
| BG002 |
| 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 | Change From Baseline in HbA1c at Week 28. | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | Posted | Least Squares Mean | Standard Error | percent change | Baseline to 28 weeks |
|
|
AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Phentermine 15mg/topiramate 100mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wesley W. Day, PhD | Vivus, Inc | 650-934-5200 | day@vivus.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
matched placebo |
|
| Los Angeles |
| California |
| United States |
| Research Site | San Francisco | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Bethesda | Maryland | United States |
| Research Site | Austin | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| protocol non-compliance |
|
| requirement for restricted medication |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Absolute Weight Change (kg) From Baseline to Week 28 | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | Posted | Least Squares Mean | Standard Error | kg | Baseline to 28 weeks |
|
|
|
|
| 5 |
| 102 |
| 85 |
| 102 |
| EG001 | Placebo | Matched placebo | 6 | 104 | 86 | 104 |
| colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| non-cardiac chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| thalamic infarction | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| paresthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypoesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (10.0) | 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.