CLINICAL TRIALS PROFILE FOR ATORVASTATIN CALCIUM

505(b)(2) Clinical Trials for atorvastatin calcium

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01964326 ↗	Actual Use Trial of Atorvastatin Calcium 10 mg	Completed	Pfizer	Phase 3	2013-10-01	The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
OTC	NCT01964326 ↗	Actual Use Trial of Atorvastatin Calcium 10 mg	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2013-10-01	The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.

All Clinical Trials for atorvastatin calcium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000941 ↗	A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
NCT00017758 ↗	The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.
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).
NCT00211939 ↗	CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients	Completed	Nabi Biopharmaceuticals	Phase 4	2005-01-01	The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.
NCT00300430 ↗	Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.	Completed	Abbott	Phase 3	2006-09-01	The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Clinical Trial Conditions for atorvastatin calcium

Condition Name

Condition Name for atorvastatin calcium
Intervention	Trials
Healthy	10
Hypercholesterolemia	7
Dyslipidemias	4
Dyslipidemia	3

Condition MeSH

Condition MeSH for atorvastatin calcium
Intervention	Trials
Dyslipidemias	10
Hypercholesterolemia	7
Heart Diseases	5
Myocardial Ischemia	4

Clinical Trial Locations for atorvastatin calcium

Trials by Country

Trials by Country for atorvastatin calcium
Location	Trials
United States	68
China	14
India	5
Egypt	4
Korea, Republic of	3

Trials by US State

Trials by US State for atorvastatin calcium
Location	Trials
Maryland	6
California	6
Minnesota	5
Washington	5
Colorado	4

Clinical Trial Progress for atorvastatin calcium

Clinical Trial Phase

Clinical Trial Phase for atorvastatin calcium
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	12
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for atorvastatin calcium
Clinical Trial Phase	Trials
Completed	49
Not yet recruiting	6
Unknown status	5

Clinical Trial Sponsors for atorvastatin calcium

Sponsor Name

Sponsor Name for atorvastatin calcium
Sponsor	Trials
National Cancer Institute (NCI)	7
Pfizer	6
Dr. Reddy's Laboratories Limited	6

Sponsor Type

Sponsor Type for atorvastatin calcium
Sponsor	Trials
Other	58
Industry	36
NIH	12

Atorvastatin calcium Market Analysis and Financial Projection

Atorvastatin Calcium: Clinical Trials, Market Analysis, and Projections

Introduction to Atorvastatin Calcium

Atorvastatin calcium, a member of the statin class of drugs, is widely used to manage high cholesterol levels and reduce the risk of cardiovascular diseases. It works by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol production in the liver. Here, we will delve into the clinical trials, market analysis, and future projections for atorvastatin calcium.

Clinical Trials and Bioequivalence Studies

Bioequivalence Studies

Recent clinical trials have focused on establishing the bioequivalence of atorvastatin calcium in different formulations. For instance, the FDA reviewed studies comparing the oral bioavailability of atorvastatin calcium oral suspension with that of the established LIPITOR (atorvastatin calcium) tablets. Two key studies, 18-VIN-0235 and C1B1023, demonstrated that the atorvastatin calcium oral suspension is bioequivalent to LIPITOR tablets in healthy adult subjects under fasting conditions[1].

• Study 18-VIN-0235: This study compared the 40 mg/10 mL atorvastatin calcium oral suspension with the 40 mg LIPITOR tablet, showing a 90% confidence interval of the ratio for atorvastatin AUC between the suspension and the tablet to be within the 80% – 125% range, indicating bioequivalence.
• Study C1B1023: This study evaluated the 80 mg/20 mL atorvastatin calcium oral suspension against the 80 mg LIPITOR tablet, with results also falling within the bioequivalence range.

These studies supported the FDA's approval of atorvastatin calcium oral suspension for treating primary hyperlipidemia, homozygous familial hypercholesterolemia, and heterozygous familial hypercholesterolemia in adults and pediatric patients (10-17 years)[1].

Clinical Use in Cardiovascular Diseases

Clinical trials and guidelines recommend the use of high-intensity statins like atorvastatin in patients with acute coronary syndrome (ACS). For example, the IMPROVE-IT trial demonstrated that adding ezetimibe to simvastatin significantly reduced cardiovascular events compared to simvastatin alone. This suggests that combining atorvastatin with other lipid-lowering agents can provide additional benefits in managing cardiovascular risk[4].

Market Analysis

Market Size and Growth

The global atorvastatin calcium market is experiencing significant growth driven by several factors. As of 2023, the market was valued at approximately $298.3 million and is projected to reach $487.8 million by 2033, growing at a CAGR of 5% from 2024 to 2033[3][5].

Market Segments

Type Analysis

The market is segmented into biocatalysis, chemical synthesis, and others. Biocatalysis emerges as a dominant force, commanding around 39% of the market share due to its efficiency and cost-effectiveness[2].

Application Analysis

Capsules are the dominant form of administration, accounting for about 51% of the market share. This is due to their faster absorption rates, reduced side effects, and improved patient compliance compared to tablets[2].

Regional Analysis

North America holds a significant market share of around 40.1%, driven by a robust healthcare infrastructure and the presence of major industry players. The Asia Pacific region is also expected to grow substantially due to increasing government initiatives and public awareness of healthcare[2].

Drivers of Growth

Rising Cardiovascular Disease Prevalence

The increasing prevalence of cardiovascular diseases, fueled by sedentary lifestyles, poor dietary habits, and an aging population, is a primary driver of the market. Atorvastatin calcium's effectiveness in managing cholesterol levels and reducing cardiovascular risk factors makes it a crucial medication in this context[2][3].

Growing Health Awareness

Increased awareness of the importance of cholesterol management and its link to heart health is driving demand. Patients are becoming more proactive in seeking preventive measures, including medication, to reduce their risk of heart-related ailments[2].

Market Projections

Future Growth Opportunities

Expanding Emerging Markets

There is significant potential for market expansion in emerging economies where the burden of cardiovascular diseases is growing rapidly. Improving access to healthcare and rising disposable incomes in these regions will drive the demand for atorvastatin calcium[2].

Personalized Medicine

The concept of personalized medicine, tailoring atorvastatin calcium dosages based on individual genetic profiles and risk factors, presents an exciting opportunity. This approach can enhance treatment outcomes and minimize side effects, potentially revolutionizing the market[2].

Distribution Channels

The online pharmacies segment is projected to be lucrative by 2033, offering convenience and accessibility to patients. This shift is expected to further boost the market growth as more patients opt for online purchases of medications[3].

Key Takeaways

• Bioequivalence: Atorvastatin calcium oral suspension has been proven bioequivalent to LIPITOR tablets, supporting its approval for various hyperlipidemia conditions.
• Market Growth: The global atorvastatin calcium market is expected to grow at a CAGR of 5% from 2024 to 2033, driven by increasing cardiovascular disease prevalence and growing health awareness.
• Dominant Segments: Capsules are the preferred form of administration, and North America holds a significant market share.
• Future Opportunities: Emerging markets and personalized medicine are key areas for future growth.

FAQs

What is atorvastatin calcium used for?

Atorvastatin calcium is used to lower cholesterol and triglyceride levels in the blood, reducing the risk of heart disease, stroke, and other cardiovascular problems.

What are the key drivers of the atorvastatin calcium market?

The key drivers include the rising prevalence of cardiovascular diseases, growing health awareness, and the effectiveness of atorvastatin calcium in managing cholesterol levels.

What is the projected market size of atorvastatin calcium by 2033?

The global atorvastatin calcium market is projected to reach $487.8 million by 2033, growing at a CAGR of 5% from 2024 to 2033[3][5].

Which form of administration dominates the atorvastatin calcium market?

Capsules dominate the market, accounting for about 51% of the market share due to their faster absorption rates and improved patient compliance[2].

What are the future growth opportunities for the atorvastatin calcium market?

Future growth opportunities include expanding into emerging markets and the adoption of personalized medicine approaches.

Sources

1. FDA Clinical Review: "ATORVALIQ (Atorvastatin Oral Suspension)" - FDA.
2. Market.us Report: "Atorvastatin Calcium Market Size, Share | CAGR of 9.5%" - Market.us.
3. GlobeNewswire: "Atorvastatin Calcium Market to Reach $487.8 Million, Globally by 2033 at 5% CAGR" - GlobeNewswire.
4. ESCardio: "Lipidology update: targets and timing of well-established therapies" - ESCardio.
5. Allied Market Research: "Atorvastatin Calcium Market Size, Share | Forecast - 2033" - Allied Market Research.