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The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Days 1-56: Placebo |
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| VI-0521 Mid Dose | Experimental |
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| VI-0521 Top Dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Apparent Clearance (CL/F) of Phentermine and Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters. | On Days 14, 28, 42, and 56 |
| Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | On Days 14, 28, 42, and 56 |
| Area Under the Curve (AUC) of Phentermine | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. | On Days 14, 28, 42, and 56 |
| Maximum Concentration (Cmax) of Phentermine | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | On Days 14, 28, 42, and 56 |
| Area Under the Curve (AUC) of Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. | On Days 14, 28, 42, and 56 |
| Maximum Concentration (Cmax) of Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | On Days 14, 28, 42, and 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Mean percent weight change from baseline to Day 56 | 56 days |
| Change in Waist Circumference | Mean change in waist circumference from baseline to Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Hsia, M.D. | Pennington Biomedical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Baton Rouge | Louisiana | 70808 | United States | ||
| Research Facility |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Days 1-56: Placebo |
| FG001 | VI-0521 Mid Dose |
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| FG002 | VI-0521 Top Dose |
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Days 1-56: Placebo |
| BG001 | VI-0521 Mid Dose |
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Apparent Clearance (CL/F) of Phentermine and Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | L/h | On Days 14, 28, 42, and 56 |
|
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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 | Placebo: Placebo, po once daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Research | VIVUS | 650-934-5200 |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| C576188 | Qsymia |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| VI-0521 Mid Dose |
| Drug |
po once daily |
|
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| VI-0521 Top Dose | Drug | po once daily |
|
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| 56 days |
| Change in Blood Pressure | Mean change in blood pressure from baseline to Day 56 | 56 days |
| Change in OGTT of Fasting and 2-hour Glucose | Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56 | 56 days |
| Change in Lipid Parameters | Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56 | 56 days |
| Change in Visual Analog Scale (VAS) Hunger Scores | Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "not at all hungry" and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors "extremely hungry all the time" and corresponds to a VAS hunger score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how hungry you were overall during the past week:" to best describes their overall level of hunger during the past week. Research staff measure the distance between the "0.0 = not at all hungry" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure. | 56 days |
| Change in Visual Analog Scale (VAS) Satiety Scores | Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "very satisfied" and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors "not all at satisfied" and corresponds to a VAS satiety score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week:" to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the "0.0 = very satisfied" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure. | 56 days |
| Change in HOMA-IR | Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56 | 56 days |
| Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) | Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/ mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity. | 56 days |
| Marrero |
| Louisiana |
| 70072 |
| United States |
| Research Facility | Cincinnati | Ohio | 45229 | United States |
| Research Facility | Charleston | South Carolina | 29403 | United States |
| Protocol Violation |
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| BG002 | VI-0521 Top Dose |
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| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | L | On Days 14, 28, 42, and 56 |
|
|
|
| Primary | Area Under the Curve (AUC) of Phentermine | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | ng•h/mL | On Days 14, 28, 42, and 56 |
|
|
|
| Primary | Maximum Concentration (Cmax) of Phentermine | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | ng/mL | On Days 14, 28, 42, and 56 |
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| Secondary | Weight Loss | Mean percent weight change from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | Percent weight change | 56 days |
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| Secondary | Change in Waist Circumference | Mean change in waist circumference from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | cm | 56 days |
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| Secondary | Change in Blood Pressure | Mean change in blood pressure from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | mmHg | 56 days |
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| Secondary | Change in OGTT of Fasting and 2-hour Glucose | Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | mg/dL | 56 days |
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| Secondary | Change in Lipid Parameters | Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | Percent Change | 56 days |
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| Secondary | Change in Visual Analog Scale (VAS) Hunger Scores | Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "not at all hungry" and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors "extremely hungry all the time" and corresponds to a VAS hunger score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how hungry you were overall during the past week:" to best describes their overall level of hunger during the past week. Research staff measure the distance between the "0.0 = not at all hungry" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure. | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
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| Secondary | Change in Visual Analog Scale (VAS) Satiety Scores | Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "very satisfied" and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors "not all at satisfied" and corresponds to a VAS satiety score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week:" to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the "0.0 = very satisfied" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure. | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Primary | Area Under the Curve (AUC) of Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | μg•h/mL | On Days 14, 28, 42, and 56 |
|
|
|
| Primary | Maximum Concentration (Cmax) of Topiramate | A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. | PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed. | Posted | Mean | Standard Deviation | μg/mL | On Days 14, 28, 42, and 56 |
|
|
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| Secondary | Change in HOMA-IR | Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56 | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | μIU/mL | 56 days |
|
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| Secondary | Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) | Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/ mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity. | The number of subjects with values at both time points (Baseline and Day 56) | Posted | Mean | Standard Deviation | Index | 56 days |
|
|
|
| 14 |
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | VI-0521 Mid Dose | VI-0521 Mid Dose: phentermine 7.5 mg and topiramate 46 mg, po once daily | 0 | 15 | 0 | 15 | 6 | 15 |
| EG002 | VI-0521 Top Dose | VI-0521 Top Dose: phentermine 15 mg and topiramate 92 mg, po once daily | 0 | 13 | 1 | 13 | 10 | 13 |
| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Urine analysis abnormal | Investigations | Systematic Assessment |
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| Urine osmolarity increased | Investigations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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The PI may publish the result of the study 12 months or longer after termination of the study. The PI will provide the sponsor a copy of any proposed publication at least 30 days prior to submission for publication.
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 28 (Phentermine) |
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| Day 42 (Phentermine) |
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| Day 56 (Phentermine) |
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| Day 14 (Topiramate) |
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| Day 28 (Topiramate) |
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| Day 42 (Topiramate) |
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| Day 56 (Topiramate) |
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| Day 28 (Phentermine) |
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| Day 42 (Phentermine) |
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| Day 56 (Phentermine) |
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| Day 28 (Phentermine) |
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| Day 42 (Phentermine) |
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| Day 56 (Phentermine) |
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| Mean change in diastolic BP |
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| Mean Change in OGTT of 2-Hour Serum Glucose |
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| Mean Change in OGTT of Fasting Serum Insulin |
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| Mean Change in OGTT of 2-Hour Serum Insulin |
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| Mean Percent Change in LDL-C |
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| Mean Percent Change in HDL-C |
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| Mean Percent Change in TG |
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| Day 28 (Topiramate) |
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| Day 42 (Topiramate) |
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| Day 56 (Topiramate) |
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| Day 28 (Topiramate) |
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| Day 42 (Topiramate) |
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| Day 56 (Topiramate) |
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