Dyslipidemia of Obesity Intervention in Teens
NCT02956590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2024-07-05
Summary
This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.
Conditions
Interventions
- DRUG
-
Pitavastatin
Statin
- DRUG
-
Placebo
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Carelon Research
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-01
- Primary Completion
- 2023-04-21
- Completion
- 2023-06-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT00344370 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
NCT02714569 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
NCT00257686 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
NCT03011450 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
NCT03618797 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
NCT01386853 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
NCT01710007 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A
NCT05809687 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
NCT01218204 ·Status: COMPLETED ·Phase: PHASE2
-
Pleiotropic Effects of Atorvastatin in High Cardiovascular Risk Patients
NCT01013103 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
NCT00529542 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
NCT00325780 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
NCT03001817 ·Status: COMPLETED ·Phase: PHASE3
-
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies
NCT00452842 ·Status: TERMINATED
-
Effects of Hypolipemic Treatment on Adipokines
NCT01099176 ·Status: COMPLETED ·Phase: NA
-
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
NCT00249249 ·Status: COMPLETED ·Phase: PHASE3
-
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
NCT01592240 ·Status: COMPLETED ·Phase: PHASE2
-
Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
NCT00726856 ·Status: COMPLETED
-
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
NCT01256476 ·Status: COMPLETED ·Phase: PHASE4
-
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
NCT01243151 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
NCT01859455 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)
NCT01101763 ·Status: COMPLETED
-
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
NCT00640549 ·Status: TERMINATED ·Phase: PHASE4
-
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
NCT01435382 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease
NCT00293748 ·Status: COMPLETED