CLINICAL TRIALS PROFILE FOR LIPITOR

All Clinical Trials for Lipitor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00023231 ↗	Pediatric Kidney Transplant Without Calcineurin Inhibitors	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-02-01	The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure. Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.
NCT00024531 ↗	Lipitor as a Treatment for Alzheimer's Disease	Completed	Pfizer	Phase 2	2000-10-01	The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00024531 ↗	Lipitor as a Treatment for Alzheimer's Disease	Completed	Institute for the Study of Aging (ISOA)	Phase 2	2000-10-01	The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00065806 ↗	Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)	Completed	Laura Schanberg	Phase 3	2003-09-01	The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin. 3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively. 4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
NCT00079638 ↗	Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL	Completed	Kos Pharmaceuticals	Phase 4	2004-04-01	The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00094172 ↗	Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis	Completed	Immune Tolerance Network (ITN)	Phase 2	2005-05-01	Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients. Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance.

Clinical Trial Conditions for Lipitor

Condition Name

Condition Name for Lipitor
Intervention	Trials
Hypercholesterolemia	31
Healthy	18
Coronary Artery Disease	13
Hyperlipidemia	13

Condition MeSH

Condition MeSH for Lipitor
Intervention	Trials
Hypercholesterolemia	38
Dyslipidemias	23
Coronary Artery Disease	23
Myocardial Ischemia	22

Clinical Trial Locations for Lipitor

Trials by Country

Trials by Country for Lipitor
Location	Trials
United States	571
Japan	54
Canada	43
China	39
Italy	29

Trials by US State

Trials by US State for Lipitor
Location	Trials
Texas	31
California	30
Ohio	25
Florida	25
New York	23

Clinical Trial Progress for Lipitor

Clinical Trial Phase

Clinical Trial Phase for Lipitor
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	50
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Lipitor
Clinical Trial Phase	Trials
Completed	160
Terminated	20
Unknown status	17

Clinical Trial Sponsors for Lipitor

Sponsor Name

Sponsor Name for Lipitor
Sponsor	Trials
Pfizer	25
AstraZeneca	13
Merck Sharp & Dohme Corp.	10

Sponsor Type

Sponsor Type for Lipitor
Sponsor	Trials
Other	207
Industry	135
NIH	30

Lipitor: Clinical Trials, Market Analysis, and Projections

Introduction to Lipitor

Lipitor, known generically as atorvastatin calcium, is one of the most widely prescribed cholesterol-lowering medications globally. It is used to manage high cholesterol levels and reduce the risk of cardiovascular disease. Here, we will delve into recent clinical trials, market analysis, and future projections for Lipitor.

Clinical Trials and Recent Data

Landmark Trials: IDEAL and SPARCL

Historically, Lipitor has been studied extensively in landmark trials such as the IDEAL (Incremental Decreases through Aggressive Lipid Lowering) and SPARCL (Stroke Prevention by Aggressive Reduction of Cholesterol Levels) trials. These trials have provided significant insights into Lipitor's effectiveness in reducing cardiovascular events and its safety profile.

• IDEAL Trial: This trial evaluated the effect of Lipitor 80 mg in reducing multiple cardiovascular events in patients with a history of heart attack. The results highlighted Lipitor's ability to significantly lower LDL cholesterol and reduce cardiovascular risk[3].
• SPARCL Trial: This trial focused on the potential kidney function effects of Lipitor in post-stroke patients with type 2 diabetes, metabolic syndrome, and chronic kidney disease. The analysis reinforced Lipitor's safety and efficacy in these patient groups[3].

New Clinical Trial Initiatives

While the above trials are well-established, new initiatives are also underway:

• Long COVID/PASC Treatment: A recent clinical trial design by HealthBioAI involves using Lipitor (atorvastatin) in combination with Selzentry (maraviroc) to treat patients with Long COVID/Post-Acute Sequelae of COVID (PASC). This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and efficacy of this combination therapy[4].

Market Analysis

Current Market Size and Growth

The global atorvastatin calcium market is substantial and growing:

• Market Size: As of 2023, the market size was approximately USD 230.4 million and is expected to grow to USD 571.0 million by 2033, with a Compound Annual Growth Rate (CAGR) of 9.5% during the forecast period from 2024 to 2033[2].
• Market Share: North America holds a significant market share of 40.1%, with market revenues reaching USD 92.3 million. Capsules are the dominant form of administration, accounting for 51% of the market share[2].

Key Players and Market Dynamics

The atorvastatin market is highly competitive, with several key players:

• Pfizer Inc.: As the original developer of Lipitor, Pfizer continues to play a significant role in the market. The company is also developing biosimilars for other cholesterol-lowering drugs to offset declining Lipitor sales[2].
• Generic Dominance: Generic versions of atorvastatin have become prominent, offering cost-effectiveness and increased accessibility for patients. Companies like Teva Pharmaceutical Industries, Mylan Pharmaceuticals Inc., and Dr. Reddy’s Laboratories Limited are major players in the generic market[2].

Regional Analysis

The market is distributed across various regions:

• North America: Leads with a significant market share due to high healthcare spending and a large patient population.
• Europe: Also has a substantial share, driven by countries like Germany, the UK, and France.
• APAC: Countries such as China, Japan, and India are contributing to the growing demand due to increasing healthcare awareness and spending[2].

Market Projections

Future Growth

The atorvastatin market is expected to continue growing due to several factors:

• Increasing Demand: The effectiveness of atorvastatin in reducing cholesterol levels and its widespread prescription by healthcare professionals drive the demand.
• Generic Market: The availability of generic versions at competitive prices will continue to expand the market reach.
• Regulatory Compliance: Ongoing regulatory approvals and compliance will ensure the market's stability and growth[2].

Competitive Landscape

The competitive landscape is expected to remain dynamic:

• New Entrants: New companies may enter the market with innovative formulations or biosimilars.
• Strategic Collaborations: Existing players are likely to engage in partnerships, acquisitions, and collaborations to expand their market share and product offerings[2].

Key Takeaways

• Clinical Trials: Lipitor has a robust clinical trial history, with ongoing and new trials exploring its use in various conditions, including Long COVID/PASC.
• Market Size and Growth: The global atorvastatin market is projected to grow significantly, reaching USD 571.0 million by 2033 with a CAGR of 9.5%.
• Key Players: Major pharmaceutical companies, including Pfizer and generic drugmakers, dominate the market.
• Regional Analysis: North America and Europe are significant markets, with APAC regions showing promising growth.

FAQs

What is Lipitor used for?

Lipitor is used to lower cholesterol levels and reduce the risk of cardiovascular disease in patients with multiple risk factors such as family history, high blood pressure, age, low HDL cholesterol, or smoking[3].

What are the key clinical trials for Lipitor?

Key trials include the IDEAL and SPARCL trials, which have demonstrated Lipitor's efficacy in reducing cardiovascular events and its safety profile[3].

How big is the global atorvastatin market?

As of 2023, the global atorvastatin market size was approximately USD 230.4 million and is projected to grow to USD 571.0 million by 2033[2].

Who are the major players in the atorvastatin market?

Major players include Pfizer Inc., Teva Pharmaceutical Industries, Mylan Pharmaceuticals Inc., and Dr. Reddy’s Laboratories Limited, among others[2].

What is the expected growth rate of the atorvastatin market?

The market is expected to grow at a CAGR of 9.5% from 2024 to 2033[2].

Sources

1. NewAmsterdam Pharma Announces 2024 Strategic Priorities - NewAmsterdam Pharma.
2. Atorvastatin Calcium Market Size, Share | CAGR of 9.5% - Market.us.
3. New Lipitor Data Analyses from Landmark Ideal and SPARCL Trials - Pfizer.
4. HealthBioAI Announces the Acceptance by the FDA to Proceed with a Randomized Clinical Trial - HealthBioAI.