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Statins

High-Dose Statins for Low HDL Cholesterol

Phase 4
Waitlist Available
Led By Craig D Williams
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Screening visit LDL-c or non-HDL-c (for patients with TG 200-500 mg/dL) in range requiring therapy based on National Cholesterol Education Program (NCEP) guidelines
Working phone number for follow-up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is designed to study the effects of two commonly used statin medications on HDLc concentrations.

Who is the study for?
This trial is for adults with low HDL (good cholesterol) levels who need treatment based on guidelines. They must have a primary care provider, working phone number, and not be pregnant or breastfeeding. People taking certain other drugs, with unstable heart disease, very high triglycerides, liver issues, heavy alcohol use or known allergies to the study drugs cannot join.Check my eligibility
What is being tested?
The trial tests two high-dose statin medications—80mg of simvastatin and atorvastatin—to see how they affect HDL cholesterol levels and particle functionality. It's part of research to understand if higher HDL can help reverse artery plaque buildup.See study design
What are the potential side effects?
Potential side effects include muscle pain or weakness, liver problems indicated by abnormal blood tests, digestive issues like nausea or constipation, increased blood sugar levels which may lead to diabetes risk in some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bad cholesterol levels are high enough to need treatment, according to national guidelines.
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I have a working phone number for follow-ups.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HDL cholesterol
Secondary outcome measures
HS-CRP, apolipoprotein A1 and B

Trial Design

2Treatment groups
Active Control
Group I: 2Active Control1 Intervention
Atorvastatin 80 mg
Group II: 1Active Control1 Intervention
Aimvastatin 80 mg

Find a Location

Who is running the clinical trial?

Indiana UniversityOTHER
976 Previous Clinical Trials
983,297 Total Patients Enrolled
Oregon State UniversityOTHER
49 Previous Clinical Trials
8,301 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
966 Previous Clinical Trials
6,845,671 Total Patients Enrolled

Media Library

Atorvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT00736463 — Phase 4
High-Density Lipoprotein Research Study Groups: 2, 1
High-Density Lipoprotein Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT00736463 — Phase 4
Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00736463 — Phase 4

Frequently Asked Questions

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

What is the general purpose of a two-drug regimen?

"Lipidemias can be addressed with 2, and it has also proven to be effective when managing postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

Are participants being actively sought out for this clinical investigation?

"This clinical trial is no longer taking on new patients. It was initially posted in January of 2005, with the last update occuring in July 2011. For those looking for other studies, there are 5 trials involving cholesterol and HDL levels as well as 103 investigations actively recruiting participants."

Answered by AI

Is this research a pioneering effort?

"There is currently a wealth of activity surrounding drug 2, with 103 active trials spanning 46 countries and 348 cities. The commencement of this research dates back to 2005 when Merck Sharp & Dohme LLC sponsored an 80 patient Phase 4 trial which has since been concluded alongside 710 other studies."

Answered by AI

Has the FDA approved the use of 2 for therapeutic purposes?

"There is ample evidence supporting the safety of this treatment, so it was assigned a score of 3 on our scale. This therapy has received approval for Phase 4 trials."

Answered by AI

How many subjects are currently enrolled in this investigation?

"At present, this clinical trial is not searching for new participants; it was initially posted on January 1st 2005 and most recently updated July 20th 2011. Alternatively, if you seek other studies there are presently five research projects recruiting patients with cholesterol/HDL issues. Additionally, 103 trials involve active recruitment of applicants."

Answered by AI
~4 spots leftby Mar 2025