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The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) | Experimental | Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily |
|
| Phentermine 30mg | Active Comparator | Weeks 1-8: Phentermine 30mg oral capsule, once daily |
|
| Placebo | Placebo Comparator | Weeks 1-8: Placebo oral capsule, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 | Drug | Phentermine/Topiramate Top Dose 15 mg/92 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM | The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM | The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Anniston | Alabama | 36207 | United States | ||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38304225 | Derived | Bays HE, Hsia DS, Nguyen LT, Peterson CA, Varghese ST. Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study. Obes Pillars. 2024 Jan 8;9:100099. doi: 10.1016/j.obpill.2024.100099. eCollection 2024 Mar. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) | Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2021 | Apr 30, 2024 |
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| Phentermine | Drug | Phentermine 30 mg capsule |
|
| Placebo | Drug | Inactive oral capsule |
|
| Baseline to Week 8 |
| Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic | The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure. | Baseline to Week 8 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Clinical Site | Lincoln | California | 95648 | United States |
| Clinical Site | Long Beach | California | 90806 | United States |
| Clinical Site | Sacramento | California | 95821 | United States |
| Clinical Site | Spring Valley | California | 91978 | United States |
| Clinical Site | Upland | California | 91786 | United States |
| Clinical Site | Washington D.C. | District of Columbia | 20011 | United States |
| Clinical Site | Coral Gables | Florida | 33134 | United States |
| Clinical Site | Miami | Florida | 33155 | United States |
| Clinical Site | Port Orange | Florida | 23227 | United States |
| Clinical Site | Brownsburg | Indiana | 46112 | United States |
| Clinical Site | Evansville | Indiana | 47714 | United States |
| Clinical Site | Wichita | Kansas | 67207 | United States |
| Clinical Site | Lexington | Kentucky | 40509 | United States |
| Clinical Site | Louisville | Kentucky | 40213 | United States |
| Clinical Site | Baton Rouge | Louisiana | 70808 | United States |
| Clinical Site | Kansas City | Missouri | 64114 | United States |
| Clinical Site | Butte | Montana | 59701 | United States |
| Clinical Site | Cary | North Carolina | 27518 | United States |
| Clinical Site | Eugene | Oregon | 97404 | United States |
| Clinical Site | Columbia | South Carolina | 29223 | United States |
| Clinical Site | Knoxville | Tennessee | 37920 | United States |
| Clinical Site | Friendswood | Texas | 77546 | United States |
| Clinical Site | North Richland Hills | Texas | 76180 | United States |
| Clinical Site | San Antonio | Texas | 78215 | United States |
| Clinical site | Salt Lake City | Utah | 84124 | United States |
| Clinical Site | Norfolk | Virginia | 23502 | United States |
| FG001 | Phentermine 30mg | Weeks 1-8: Phentermine 30mg oral capsule, once daily Phentermine: Phentermine 30 mg capsule |
| FG002 | Placebo | Weeks 1-8: Placebo oral capsule, once daily Placebo: Inactive oral capsule |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) | Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule |
| BG001 | Phentermine 30mg | Weeks 1-8: Phentermine 30mg oral capsule, once daily Phentermine: Phentermine 30 mg capsule |
| BG002 | Placebo | Weeks 1-8: Placebo oral capsule, once daily Placebo: Inactive oral capsule |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hypertensive status | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes Status | Count of Participants | Participants |
| ||||||||||||||||
| Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m2 |
|
| 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 to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM | The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities. | Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:
| Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Week 8 |
|
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| Secondary | Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM | The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities. | Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:
| Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic | The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure. | Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as:
| Posted | Least Squares Mean | Standard Error | mmHg | Baseline to Week 8 |
|
Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
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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 | VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) | Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule | 0 | 190 | 0 | 190 | 66 | 190 |
| EG001 | Phentermine 30mg | Weeks 1-8: Phentermine 30mg oral capsule, once daily Phentermine: Phentermine 30 mg capsule | 0 | 191 | 1 | 191 | 44 | 191 |
| EG002 | Placebo | Weeks 1-8: Placebo oral capsule, once daily Placebo: Inactive oral capsule | 0 | 184 | 0 | 184 | 6 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 24.1 | Systematic Assessment | chest pain or discomfort due to coronary heart disease |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
Participants with baseline blood pressure greater than 140/90 were excluded. Of the 565 total participants randomized and treated with study drug, 180 participants were excluded from the per protocol population used for the primary analysis due to participants' reluctance or inability to properly complete end of study ABPM assessments.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lan Nguyen | Vivus LLC | 650-934-5246 | clinical@vivus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Apr 30, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C576188 | Qsymia |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Medical Diagnosis of Hypertension Treated with 0 to 2 Antihypertensive Agents |
|
| Medical Diagnosis of Hypertension Treated with 3 or More Antihypertensive Agents |
|
| Prediabetes |
|
| Gestational Diabetes |
|
| Borderline Diabetes |
|
| Not Diabetic |
|
| Diastolic Blood Pressure |
|
| ANCOVA |
| 0.0059 |
| Other |
If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed. |
| ANCOVA | 0.1867 | Other | If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed. |
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
| OG002 | Placebo | Weeks 1-8: Placebo oral capsule, once daily Placebo: Inactive oral capsule |
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|
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| Phentermine 30mg |
Weeks 1-8: Phentermine 30mg oral capsule, once daily Phentermine: Phentermine 30 mg capsule |
| OG002 | Placebo | Weeks 1-8: Placebo oral capsule, once daily Placebo: Inactive oral capsule |
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