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Statins

Pitavastatin for High Cholesterol (DO IT! Trial)

Phase 3
Waitlist Available
Research Sponsored by HealthCore-NERI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

DO IT! Trial Summary

This trial will test if pitavastatin is effective and safe for people at high risk for atherosclerosis, which could lead to primary prevention of adult cardiovascular disease.

Eligible Conditions
  • High Cholesterol
  • Obesity

DO IT! Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)
Secondary outcome measures
Magnetic Resonance Imaging
the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)
the effect of pitavastatin versus placebo on composite outcome of Number of Participants With Abnormal Laboratory Values and/or Adverse Events
+9 more

DO IT! Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PitavastatinActive Control1 Intervention
Study Drug
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,611 Total Patients Enrolled
Carelon ResearchLead Sponsor
73 Previous Clinical Trials
216,633 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,472 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which type of person does this research project require?

"This trial is looking for 122 individuals aged 10 to 19 who suffer from obesity. To qualify, patients must meet the following conditions: having a BMI in the 85th percentile or higher (according to the CDC BMI chart), giving consent to participate in the study, and being available for the next two years."

Answered by AI

Is there a broad base of research to support the use of Pitavastatin?

"There are 4 ongoing clinical studies for the efficacy of pitavastatin with 2 in the final stage of testing. Many of the 172 locations for these trials are based in Beijing, but there are others spread throughout the world."

Answered by AI

Does age restriction exist for potential participants of this clinical trial?

"To be eligible for this particular trial, minors between the ages of 10 to 19 years old inclusive are able to participate."

Answered by AI

Are there any harmful side-effects to taking Pitavastatin?

"Pitavastatin is in Phase 3 trials, which implies that while there is data supporting its efficacy, there is extensive data affirming its safety—our team at Power rated it a 3."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Wisconsin
Texas
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

My Dr wanted me to get in a trail for high cholesterol, Diebetic and overweight since my insurance does not cover weight loss drugs.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Dyslipidemia of Obesity Intervention in Teens
2018. "Dyslipidemia of Obesity Intervention in Teens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02956590.
~18 spots leftby Apr 2025
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