CLINICAL TRIALS PROFILE FOR TRICOR

All Clinical Trials for tricor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00186537 ↗	Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.	Completed	Abbott	N/A	2003-09-01	Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
NCT00186537 ↗	Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.	Completed	Stanford University	N/A	2003-09-01	Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
NCT00195793 ↗	A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin	Completed	Abbott	Phase 3	2004-08-01	The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.
NCT00251680 ↗	Efficacy of Lapaquistat Acetate in Subjects Currently Treated With Lipid-Lowering Therapy.	Completed	Takeda	Phase 3	2005-10-01	The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes mellitus.
NCT00262964 ↗	Obesity and Nonalcoholic Fatty Liver Disease	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2004-10-01	The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.

Clinical Trial Conditions for tricor

Condition Name

Condition Name for tricor
Intervention	Trials
Hypertriglyceridemia	4
Healthy	4
Type 2 Diabetes	1
Diabetes Complications	1

Condition MeSH

Condition MeSH for tricor
Intervention	Trials
Hypertriglyceridemia	4
Hyperlipoproteinemias	3
Hyperlipidemias	3
Diabetes Mellitus	3

Clinical Trial Locations for tricor

Trials by Country

Trials by Country for tricor
Location	Trials
United States	53
Canada	2
Slovakia	1
India	1
Estonia	1

Trials by US State

Trials by US State for tricor
Location	Trials
Ohio	4
Missouri	4
Illinois	4
Virginia	3
Texas	3

Clinical Trial Progress for tricor

Clinical Trial Phase

Clinical Trial Phase for tricor
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for tricor
Clinical Trial Phase	Trials
Completed	16
Terminated	2
Unknown status	2

Clinical Trial Sponsors for tricor

Sponsor Name

Sponsor Name for tricor
Sponsor	Trials
Washington University School of Medicine	2
Mutual Pharmaceutical Company, Inc.	2
National Heart, Lung, and Blood Institute (NHLBI)	2

Sponsor Type

Sponsor Type for tricor
Sponsor	Trials
Industry	13
Other	13
NIH	7

Tricor Market Analysis and Financial Projection

TRICOR (Fenofibrate): Clinical Trials, Market Analysis, and Projections

Introduction

TRICOR, also known as fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist used to manage various lipid disorders. This article will delve into the current clinical trials, market analysis, and future projections for TRICOR.

Clinical Indications and Usage

TRICOR is indicated for the treatment of primary hypercholesterolemia or mixed dyslipidemia and severe hypertriglyceridemia in adult patients. It is used as an adjunct to diet to reduce elevated LDL-C, Total-C, triglycerides, and apolipoprotein B, while increasing HDL-C[1].

Ongoing and Recent Clinical Trials

Metabolic Syndrome Study

A prospective observational study is currently assessing the effectiveness of TRICOR in patients with hypertriglyceridemia as part of a combination therapy with statins. This study aims to evaluate the impact of TRICOR on patients with metabolic syndrome, a cluster of risk factors leading to metabolic dysregulation and atherosclerotic cardiovascular diseases[4].

Historical Trials

The ACCORD Lipid trial, a randomized placebo-controlled study, investigated the effect of fenofibrate plus statin combination therapy on cardiovascular outcomes in patients with type 2 diabetes. The trial showed a non-significant 8% relative risk reduction in major adverse cardiovascular events (MACE) and a significant 11% reduction in total cardiovascular disease events[1].

Market Analysis

Current Market

The global market for lipid-lowering drugs, including fenofibrate, is substantial due to the high prevalence of cardiovascular diseases. TRICOR, as a part of this market, benefits from its established use in managing lipid disorders.

Growth Projections

The broader pharmaceutical market, particularly the segment focused on cardiovascular diseases, is expected to grow significantly. The global clinical trials market, which includes trials for drugs like TRICOR, is projected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a CAGR of 7.1%[3].

Market Trends and Drivers

Increasing Prevalence of Chronic Diseases

The rising number of patients with chronic diseases such as hypercholesterolemia and hypertriglyceridemia drives the demand for effective lipid-lowering therapies like TRICOR.

Regulatory Environment

Regulatory changes and guidelines can significantly impact the market. For instance, the relaxation of restrictions on virtual and hybrid annual general meetings (AGMs) during the COVID-19 pandemic highlights the adaptability and resilience of pharmaceutical companies, including those involved in the distribution and research of TRICOR[2].

Challenges and Considerations

Safety and Efficacy

TRICOR therapy is associated with several safety considerations, including the risk of liver enzyme elevations and potential impacts on renal function. Regular monitoring of liver function and renal status is recommended[1].

Patient Compliance and Education

Patient compliance and education are crucial for the effective use of TRICOR. Studies have shown that technological difficulties and lack of awareness among non-tech savvy shareholders (in a broader corporate context) can hinder the adoption of new technologies and therapies[2].

Future Projections

Market Growth

Given the increasing demand for lipid-lowering therapies and the growing global clinical trials market, TRICOR is likely to remain a significant player in the pharmaceutical industry. The market for lipid-lowering drugs is expected to continue growing, driven by the rising prevalence of cardiovascular diseases.

Technological Advancements

The integration of digital solutions in healthcare, such as virtual and hybrid AGMs, may also influence the future of drug trials and patient engagement. Companies like Tricor Hong Kong are already leveraging digital transformation to enhance corporate governance and shareholder engagement, which could have indirect benefits for the pharmaceutical sector[2].

Key Takeaways

• Clinical Indications: TRICOR is used to treat primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia.
• Ongoing Trials: Studies are evaluating TRICOR's effectiveness in patients with metabolic syndrome.
• Market Analysis: The global market for lipid-lowering drugs is growing, driven by the prevalence of chronic diseases.
• Growth Projections: The clinical trials market, including those for TRICOR, is expected to grow significantly by 2032.
• Challenges: Safety considerations, patient compliance, and technological difficulties are key challenges.

FAQs

What are the primary indications for TRICOR?

TRICOR is indicated for the treatment of primary hypercholesterolemia or mixed dyslipidemia and severe hypertriglyceridemia in adult patients.

What are the potential side effects of TRICOR?

TRICOR therapy can lead to liver enzyme elevations, impacts on renal function, and in rare cases, hepatocellular, chronic active, and cholestatic hepatitis[1].

How does the ACCORD Lipid trial impact the understanding of TRICOR's efficacy?

The ACCORD Lipid trial showed a non-significant reduction in major adverse cardiovascular events and a significant reduction in total cardiovascular disease events, providing insights into TRICOR's cardiovascular benefits[1].

What is the projected growth rate of the global clinical trials market?

The global clinical trials market is projected to grow at a CAGR of 7.1% from 2024 to 2032[3].

How does digital transformation affect the pharmaceutical industry, including TRICOR?

Digital transformation can enhance patient engagement, streamline clinical trials, and improve corporate governance, indirectly benefiting the pharmaceutical sector by increasing efficiency and compliance[2].

Sources

1. TRICOR (fenofibrate) Tablet, for oral use - FDA Label.
2. Tricor and Quinlan Jointly Announce Research Findings on Global Digital AGM Trends - Tricor Global.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032] - Fortune Business Insights.
4. Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome - Veeva Systems.