CLINICAL TRIALS PROFILE FOR CLOFIBRATE

All Clinical Trials for clofibrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00238004 ↗	The Low HDL On Six Weeks Statin Therapy (LOW) Study	Unknown status	Craigavon Area Hospital	Phase 4	2005-11-01	Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing. Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.
NCT00000483 ↗	Coronary Drug Project Mortality Surveillance	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	1981-06-01	To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
NCT00000482 ↗	Coronary Drug Project	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1965-04-01	To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.

Clinical Trial Conditions for clofibrate

Condition Name

Condition Name for clofibrate
Intervention	Trials
Coronary Disease	2
Heart Diseases	2
Myocardial Infarction	2

Condition MeSH

Condition MeSH for clofibrate
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	3
Heart Diseases	2

Clinical Trial Locations for clofibrate

Trials by Country

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Trials by Country for clofibrate
Location	Trials
United States	1
Brazil	1
United Kingdom	1
Canada	1
Denmark	1

Trials by US State

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−

Trials by US State for clofibrate
Location	Trials
Maryland	1

Clinical Trial Progress for clofibrate

Clinical Trial Phase

Clinical Trial Phase for clofibrate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for clofibrate
Clinical Trial Phase	Trials
Completed	5
Unknown status	2
Terminated	1

Clinical Trial Sponsors for clofibrate

Sponsor Name

Sponsor Name for clofibrate
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Centre for Addiction and Mental Health	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1

Sponsor Type

Sponsor Type for clofibrate
Sponsor	Trials
Other	8
NIH	2
Industry	1

Clofibrate: Clinical Trials, Market Analysis, and Projections

Introduction to Clofibrate

Clofibrate is a fibrate drug used to manage high cholesterol and triglyceride levels in the blood. It belongs to a class of medications known as fibrates, which are preferred by doctors for their efficacy in improving lipid profiles.

Clinical Trials and Efficacy

Historical Trials

Clofibrate has been studied in various clinical trials over the years. One notable study compared the hypolipidemic effects of halofenate, clofibrate, and placebo in 29 patients with type IV hyperlipoproteinemia. This trial highlighted the ability of clofibrate to reduce lipid levels, although it also noted other laboratory and clinical effects that needed careful monitoring[4].

Current Context

While clofibrate is not as prominently featured in recent clinical trials as other fibrates like fenofibrate, its historical data continues to inform the broader understanding of fibrate efficacy. Recent trials have focused more on newer fibrates, but the foundational work done with clofibrate remains relevant.

Market Analysis

Global Fibrate Drugs Market

The global fibrate drugs market, which includes clofibrate, is anticipated to grow significantly over the coming years. Here are some key points:

• Market Size: The fibrate drugs market was valued at USD 3.18 billion in 2023 and is expected to grow to USD 5.04 billion by 2032, exhibiting a CAGR of 5.3% during the forecast period[2][3].
• Segmentation: The market is segmented by drug type, with clofibrate being one of the key segments along with fenofibrates, fenofibric acids, and gemfibrozil. Fenofibrates are currently the dominant segment due to their high efficacy and increasing patient base[2][3].

Regional Market Share

• North America: This region holds the largest market share due to the high incidence of coronary heart disease and elevated serum cholesterol levels. The detection of CHD and the need for lipid-lowering therapies drive the market in this region[2][3].
• Asia Pacific: This region is expected to expand at the highest CAGR during the forecast period, driven by a large population with sedentary lifestyles, smoking and drinking habits, and increasing prevalence of diabetes and coronary artery disease[2].

Market Projections

Growth Drivers

• Increasing Triglyceride Levels: Rising levels of triglycerides among a large group of patients are a primary driver for market growth. High risks of heart attack and stroke associated with elevated triglycerides and low cholesterol levels further drive the demand for fibrate drugs[2][3].
• Lifestyle Factors: A large population pool using alcohol excessively and leading sedentary lifestyles increases the risk of dyslipidemia, contributing to market growth[2].
• Research and Development: Ongoing research and development activities for managing high triglyceride levels will continue to support the growth of the fibrate drugs market[2].

Competitive Insights

• Branded vs Generic: The branded segment currently dominates the market due to patents owned by key players. However, the entry of generic drug manufacturers is expected to increase competition in the coming years[2].
• Key Players: Companies like Viatris Inc., Aurobindo Pharma, Lupin Pharmaceuticals, Inc., and AbbVie Inc. are major players in the fibrate drugs market[2].

Product Form and Distribution

Product Forms

• Tablets and Capsules: Fibrate drugs, including clofibrate, are available in tablet and capsule forms. The tablets segment is expected to witness significant growth due to the ability to accommodate higher doses and longer shelf life[2].

Distribution Channels

• Hospital & Retail Pharmacies: These channels accounted for the largest market share in 2023, driven by the high incidence of heart diseases and the growing number of patients requiring lipid-lowering therapies[2].

Key Takeaways

• Market Growth: The global fibrate drugs market, including clofibrate, is projected to grow at a CAGR of 5.3% from 2023 to 2032.
• Dominant Segment: Fenofibrates currently dominate the market, but clofibrate remains a significant part of the fibrate drugs segment.
• Regional Focus: North America holds the largest market share, while the Asia Pacific region is expected to grow at the highest CAGR.
• Growth Drivers: Increasing triglyceride levels, lifestyle factors, and ongoing research and development activities drive market growth.

FAQs

What is the current market size of the global fibrate drugs market?

The global fibrate drugs market was valued at USD 3.18 billion in 2023[2].

What is the projected growth rate of the fibrate drugs market?

The market is expected to grow at a CAGR of 5.3% from 2023 to 2032[2].

Which segment dominates the fibrate drugs market?

The fenofibrate segment currently dominates the market due to its high efficacy and increasing patient base[2][3].

What are the primary drivers of the fibrate drugs market growth?

The primary drivers include increasing triglyceride levels, high risks of heart attack and stroke, lifestyle factors, and ongoing research and development activities[2].

Which region is expected to grow at the highest CAGR?

The Asia Pacific region is expected to expand at the highest CAGR during the forecast period[2].

What are the common forms of fibrate drugs?

Fibrate drugs, including clofibrate, are available in tablet and capsule forms, with the tablets segment expected to witness significant growth[2].

Sources

1. NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib - NewAmsterdam Pharma.
2. Fibrate Drugs Market Size, Demand, Trends, Report, 2024-2032 - Polaris Market Research.
3. Global Fibrate Drugs Market: Global Industry Analysis and Forecast (2023 - 2029) - Maximize Market Research.
4. One-year trials with halofenate, clofibrate, and placebo - PubMed.