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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
18 years of age or older
Must not have
Known history or diagnosis of clinical hepatic failure (example: variceal bleeding, ascites, INR>1.3)
Age < 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 30 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
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.
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.
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 belowSelect...
My bad cholesterol levels are high enough to need treatment, according to national guidelines.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of severe liver problems.
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I am under 18 years old.
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I am taking medication that interacts with Zocor or Lipitor.
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I haven't had any recent heart problems or unstable chest pain.
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I have been diagnosed with HIV/AIDS.
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I am allergic to or cannot take atorvastatin or simvastatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,035 Previous Clinical Trials
1,218,899 Total Patients Enrolled
Oregon State UniversityOTHER
50 Previous Clinical Trials
8,354 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,003 Previous Clinical Trials
7,412,310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink more than 2 alcoholic drinks per day on average, which is equivalent to more than 14 drinks per week.I have a history of severe liver problems.My bad cholesterol levels are high enough to need treatment, according to national guidelines.I am under 18 years old.I am taking medication that interacts with Zocor or Lipitor.I haven't had any recent heart problems or unstable chest pain.I have a working phone number for follow-ups.I have been diagnosed with HIV/AIDS.I am allergic to or cannot take atorvastatin or simvastatin.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 2
- Group 2: 1
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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