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Study Comparing Rosuvastatin and Fenofibrate with Pravastatin and Fenofibrate for Patients with Mixed Dyslipidemia at High Risk of Heart Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as dyslipidemia, which involves having abnormal levels of lipids, such as cholesterol and triglycerides, in the blood. The study will compare the effects of two different treatments on patients with this condition. One treatment involves a combination of two medications: rosuvastatin and fenofibrate. The other treatment uses a medication called Pravafenix, which is a combination of pravastatin sodium and fenofibrate.

The purpose of the study is to evaluate the effectiveness and safety of these treatments over a period of 12 weeks. Participants will be randomly assigned to receive either the rosuvastatin and fenofibrate combination or Pravafenix. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps ensure that the results are not influenced by expectations or bias.

Throughout the study, participants will take the medication in the form of hard capsules by mouth. The main goal is to see how well each treatment lowers levels of a type of cholesterol called Low-Density Lipoprotein (LDL), which is often referred to as "bad" cholesterol. The study will also look at changes in other types of cholesterol and triglycerides, as well as monitor any side effects that may occur. The trial aims to provide valuable information on which treatment might be more effective for patients with mixed dyslipidemia who are at high risk for heart disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include being over 18 years old, having been treated with Pravafenix for at least 3 months, and having a high or very high risk of coronary heart disease.
Step 2
Randomization
Participants are randomly assigned to one of two groups. One group receives a combination of rosuvastatin 20 mg and fenofibrate 160 mg, while the other group continues with Pravafenix (pravastatin 40 mg and fenofibrate 160 mg).
Both medications are administered orally in the form of hard capsules.
Step 3
Treatment period
The treatment period lasts for 12 weeks. During this time, participants take their assigned medication daily.
Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes measuring cholesterol levels and checking for any side effects.
Step 4
Follow-up assessments
At the end of the 12-week period, follow-up assessments are conducted to evaluate changes in cholesterol levels and overall health.
The primary focus is on the change in low-density lipoprotein (LDL) cholesterol levels. Secondary assessments include changes in other cholesterol types and triglycerides.
Step 5
Final evaluation
A final evaluation is performed to determine the overall effectiveness and safety of the treatment.
The study aims to demonstrate the superiority of the rosuvastatin and fenofibrate combination over Pravafenix in reducing LDL cholesterol in high-risk patients.

Who can join the trial?

7 criteria

Must be a male or female over 18 years old.
Must have been treated with Pravafenix® for at least 3 months for a condition called mixed **dyslipidemia**, which means having abnormal levels of fats in the blood.
Must be at high or very high risk for **coronary heart disease** (CHD), which is a condition affecting the heart's blood vessels. This is determined by specific guidelines and includes factors like high cholesterol, high blood pressure, or having diabetes.
Must have a certain level of **Low-Density Lipoprotein Cholesterol (LDL-C)**, which is often called "bad cholesterol." For very high-risk patients, it should be 55 mg/dL or higher, and for high-risk patients, it should be 70 mg/dL or higher.
Must be able to follow all the procedures required in the trial.
Must provide written consent to participate in the trial, which means agreeing to join the study by signing a form.
If the participant is a woman who can have children, she must use a highly effective method of birth control from the start of the trial until the last dose of the trial medication.

Who cannot join the trial?

5 criteria

Patients with **dyslipidaemia** that is not controlled. Dyslipidaemia is a condition where there are unhealthy levels of fats, like cholesterol, in the blood.
Patients who are not at the target level for **Low-Density Lipoprotein Cholesterol (LDL-C)**. LDL-C is often called "bad cholesterol" because high levels can lead to heart problems.
Patients who are not considered high or very high risk for **coronary heart disease**. Coronary heart disease is a condition where the blood vessels supplying the heart are narrowed or blocked.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

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Athens Medical Center S.A.
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Thessaloniki, Greece

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Investigated drugs

Rosuvastatin
is a medication used to lower cholesterol levels in the blood. It works by reducing the amount of cholesterol made by the liver, which helps prevent heart disease and stroke. In this trial, it is combined with another medication to see if it is more effective in patients with mixed dyslipidemia.
Fenofibrate
is used to help reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these fats can lead to clogged arteries, which increases the risk of heart disease and stroke. In this study, it is used in combination with other medications to evaluate its effectiveness in managing cholesterol levels.
Pravastatin
is another cholesterol-lowering medication that helps prevent heart disease and stroke by reducing the production of cholesterol in the liver. It is being compared in this trial to see how it performs in combination with fenofibrate against other treatment options for patients with mixed dyslipidemia.

What is already known about the treatment

Rosuvastatin and Fenofibrate Combination
This medication is administered orally in the form of a fixed-dose combination tablet. It is currently being studied in a phase III clinical trial to assess its efficacy and safety in treating mixed dyslipidaemia, a condition characterized by abnormal levels of lipids in the blood. The main therapeutic indication is to manage cholesterol levels, particularly in patients at high or very high risk of coronary heart disease. Rosuvastatin works by inhibiting an enzyme involved in cholesterol production in the liver, while fenofibrate helps to reduce triglycerides and increase high-density lipoprotein (HDL) cholesterol. This combination falls under the pharmacological classification of lipid-lowering agents.
Pravafenix® (Pravastatin and Fenofibrate Combination)
This medication is also administered orally as a fixed-dose combination tablet. It is being compared in the same clinical trial to evaluate its effectiveness in patients with mixed dyslipidaemia. The primary therapeutic use is to control cholesterol levels in individuals at risk of coronary heart disease. Pravastatin functions by blocking an enzyme necessary for cholesterol synthesis in the liver, and fenofibrate aids in lowering triglycerides and boosting HDL cholesterol. This combination is classified as a lipid-lowering agent.

Investigated diseases

Dyslipidemia – Dyslipidemia is a condition characterized by abnormal levels of lipids in the blood, such as cholesterol and triglycerides. It often involves high levels of low-density lipoprotein (LDL) cholesterol, low levels of high-density lipoprotein (HDL) cholesterol, or elevated triglycerides. This imbalance can lead to the buildup of fatty deposits in blood vessels, which may restrict blood flow. Over time, this can contribute to the development of cardiovascular diseases. The condition may not present noticeable symptoms initially, making regular monitoring of blood lipid levels important. Lifestyle factors, genetics, and other health conditions can influence the progression of dyslipidemia.