A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents

NCT ID: NCT02714062

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-30

Brief Summary

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

Conditions

Pediatric Obesity; Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Days 1-56: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

po once daily

VI-0521 Mid Dose

• Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
• Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)

Group Type: EXPERIMENTAL

VI-0521 Mid Dose

Intervention Type: DRUG

po once daily

VI-0521 Top Dose

• Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
• Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
• Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
• Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)

Group Type: EXPERIMENTAL

VI-0521 Top Dose

Intervention Type: DRUG

po once daily

Interventions

Placebo

po once daily

Intervention Type: DRUG

VI-0521 Mid Dose

po once daily

Intervention Type: DRUG

VI-0521 Top Dose

po once daily

Intervention Type: DRUG

Other Intervention Names

Sugar Pill; Phentermine/Topiramate; Phentermine/Topiramate

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent;
• Provide written assent (of study subject);
• Adolescent ≥12 and <18 years of age;
• Have a BMI ≥ the 95th percentile of BMI for age and gender;
• Female subjects must be using adequate contraception;
• Willing and able to comply with all study requirements

Exclusion Criteria

• Condition or disease interfering with metabolism;
• Any medical treatment with insulin;
• Hyperthyroidism, or clinically significant hypothyroidism;
• Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
• Use of chronic systemic glucocorticoid or steroid therapy;
• History of any eating disorders;
• Any history of laxative abuse;
• Prior bariatric surgery;
• Any history of nephrolithiasis;
• Any history of epilepsy, or treatment with anti-seizure medications;
• Positive urine drug screen;
• Current smoker or smoking cessation within the previous 3 months of screening;
• Obesity of a known genetic or endocrine origin;
• Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
• Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
• Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
• Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VIVUS LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Hsia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research

Locations

Research Facility

Baton Rouge, Louisiana, United States

Research Facility

Marrero, Louisiana, United States

Research Facility

Cincinnati, Ohio, United States

Research Facility

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

OB-402

Identifier Type: -

Identifier Source: org_study_id