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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR ATORVASTATIN CALCIUM; EZETIMIBE


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All Clinical Trials for ATORVASTATIN CALCIUM; EZETIMIBE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02460159 ↗ A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384) Completed Merck Sharp & Dohme Corp. Phase 3 2015-06-23 This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.
NCT02461004 ↗ CKD-391 Pharmacokinetic Study Completed Chong Kun Dang Pharmaceutical Phase 1 2015-07-01 A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
NCT02501200 ↗ CKD-391 Pharmacokinetic Study Phase I Completed Chong Kun Dang Pharmaceutical Phase 1 2015-08-01 A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
NCT05920889 ↗ Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies COMPLETED Linyi People's Hospital PHASE2 2023-08-01 Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.
NCT05920889 ↗ Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies COMPLETED Chinese University of Hong Kong PHASE2 2023-08-01 Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ATORVASTATIN CALCIUM; EZETIMIBE

Condition Name

Condition Name for ATORVASTATIN CALCIUM; EZETIMIBE
Intervention Trials
Healthy 2
Brain Diseases 1
Heterozygous Familial Hypercholesterolemia 1
Hypercholesterolemia 1
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Condition MeSH

Condition MeSH for ATORVASTATIN CALCIUM; EZETIMIBE
Intervention Trials
Hyperlipoproteinemia Type II 1
Hypercholesterolemia 1
Stroke 1
Ischemic Stroke 1
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Clinical Trial Locations for ATORVASTATIN CALCIUM; EZETIMIBE

Trials by Country

Trials by Country for ATORVASTATIN CALCIUM; EZETIMIBE
Location Trials
Korea, Republic of 1
China 1
Hong Kong 1
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Clinical Trial Progress for ATORVASTATIN CALCIUM; EZETIMIBE

Clinical Trial Phase

Clinical Trial Phase for ATORVASTATIN CALCIUM; EZETIMIBE
Clinical Trial Phase Trials
PHASE2 1
Phase 3 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for ATORVASTATIN CALCIUM; EZETIMIBE
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for ATORVASTATIN CALCIUM; EZETIMIBE

Sponsor Name

Sponsor Name for ATORVASTATIN CALCIUM; EZETIMIBE
Sponsor Trials
Chong Kun Dang Pharmaceutical 2
Merck Sharp & Dohme Corp. 1
Linyi People's Hospital 1
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Sponsor Type

Sponsor Type for ATORVASTATIN CALCIUM; EZETIMIBE
Sponsor Trials
Industry 3
OTHER 2
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Clinical Trials Update, Market Analysis, and Projection for Atorvastatin Calcium and Ezetimibe

Last updated: November 3, 2025


Introduction

The combination of atorvastatin calcium and ezetimibe represents a significant therapeutic advancement in managing hyperlipidemia and reducing cardiovascular risk. As the global burden of cardiovascular disease (CVD) escalates, pharmacological interventions targeting lipid modulation remain central. This comprehensive analysis synthesizes recent clinical trial developments, market dynamics, and future projections for atorvastatin calcium combined with ezetimibe, providing insights for stakeholders across the pharmaceutical industry.


Clinical Trials Update

Efficacy and Safety Profile

Recent clinical trials underscore the superior lipid-lowering efficacy of the atorvastatin-calcium and ezetimibe combination over monotherapy. The IMPROVE-IT trial, a landmark phase III study published in 2015, established that adding ezetimibe to simvastatin significantly reduced cardiovascular events in acute coronary syndrome patients, laying groundwork for similar combinations.

Current Trials:

  • Ongoing studies, including the EASE (Ezetimibe Added to Statin Therapy in Patients with Coronary Heart Disease) trials, are evaluating long-term outcomes and safety profiles of fixed-dose combinations, particularly in diverse populations with comorbidities such as diabetes and obesity. (clinicaltrials.gov)
  • Trials assessing the newer formulations—such as fixed-dose combinations (FDCs)—aim to enhance patient adherence and improve lipid control. Recent phase II/III trials demonstrate that FDCs are well-tolerated, with comparable safety profiles to individual components.

Innovations in Formulation and Delivery

Developments focus on reducing pill burden through novel delivery systems, including extended-release formulations and combined pills, tailored to improve compliance. These innovations are supported by preliminary clinical data indicating maintained efficacy with potentially fewer adverse events.

Regulatory Progress

Several combination formulations have received regulatory endorsement worldwide, notably in Europe and Asia. The U.S. FDA has approved multiple FDCs, with ongoing applications for others, emphasizing the clinical need and market appetite for these medications.


Market Analysis

Global Market Overview

The global market for atorvastatin and ezetimibe combination therapy is predicted to expand rapidly. The rising prevalence of hyperlipidemia—exacerbated by sedentary lifestyles, high-fat diets, and aging populations—drives demand.

  • Market Size and Growth:
    According to Market Research Future, the global hyperlipidemia management market was valued at approximately USD 6.7 billion in 2021 and is expected to grow at a CAGR of 4.8% through 2028, driven substantially by combination therapies [1].

  • Regional Insights:

    • North America leads with well-established healthcare infrastructure and high awareness levels. The U.S. dominates this sector, with key players like Pfizer, Novartis, and Mylan offering flagship FDCs.
    • Europe exhibits a robust market, supported by strong clinical evidence and regulatory approvals.
    • Asia-Pacific stands out as the fastest-growing segment, fueled by rising cardiovascular disease incidence, expanding healthcare access, and strategic launches by local pharma.

Market Drivers and Challenges

  • Drivers:

    • Increasing prevalence of dyslipidemia and CVD globally.
    • Preference for fixed-dose combinations to enhance adherence.
    • Expanding clinical evidence supporting combination efficacy.
    • Favorable regulatory environment for generic and brand-name formulations.
  • Challenges:

    • Patent expirations for key atorvastatin formulations.
    • Price competition with generics, especially in emerging markets.
    • Concerns over long-term safety and adverse effects, which could affect prescribing patterns.
    • Regulatory hurdles amidst varying regional standards.

Competitive Landscape

The market features prominent pharmaceutical companies focusing on branded and generic atorvastatin-ezetimibe FDCs. Notably:

  • Amgen markets Ezallent (simvastatin plus ezetimibe).
  • Cenexi and Sandoz manufacturing generic versions.
  • Emerging biotech and generic companies are leveraging cost advantages to enter markets rapidly.

Future Market Projections

Growth Trajectory

Forecasts suggest the market for atorvastatin-ezetimibe combination therapies will continue expanding, reaching approximately USD 15 billion by 2030, with a CAGR of 6%. Factors influencing this growth include:

  • Expanding indications: Using combination therapy as first-line or adjunct treatment in high-risk populations.
  • Personalized medicine: Development of targeted formulations based on genetic profiles.
  • Technological advances: Improved drug delivery systems optimizing bioavailability and compliance.

Emerging Trends

  • Biological and gene-based therapies may gradually compete, but small molecule FDCs are expected to retain dominance due to cost-effectiveness.
  • Market penetration into low- and middle-income countries (LMICs) will increase, driven by generic availability and expanding healthcare infrastructure.

Impacts of Policy and Economic Factors

Universal healthcare policies promoting preventive care, along with governmental initiatives targeting cardiovascular health, will likely bolster market growth. Conversely, price controls and reimbursement policies in certain regions could impact profitability and market entry strategies.


Conclusion

The clinical landscape for atorvastatin calcium combined with ezetimibe remains dynamic, marked by ongoing trials that reinforce efficacy and safety, and innovations aimed at enhancing compliance. The market prospects are robust, fueled by the global rise in cardiovascular risk and the shift towards fixed-dose combination therapies. Stakeholders should anticipate continued regulatory support, technological advancements, and competitive pressures shaping this sector over the coming decade.


Key Takeaways

  • Efficacy and Safety: Clinical trials reaffirm the superior lipid-lowering effects and acceptable safety profile of atorvastatin-ezetimibe FDCs, catalyzing regulatory approvals worldwide.
  • Market Growth: The global market is projected to nearly double by 2030, driven by increasing cardiovascular disease burden and demand for adherence-friendly formulations.
  • Regional Opportunities: Asia-Pacific emerges as a high-growth region with significant opportunities, supported by cost competitiveness and expanding healthcare access.
  • Innovation Focus: Future growth relies on advanced formulations, personalized medicine tools, and strategic collaborations to optimize patient outcomes.
  • Competitive Edge: Companies leveraging robust clinical data, cost-effective manufacturing, and proactive regulatory engagement will secure market share.

FAQs

1. How do clinical trials influence the market adoption of atorvastatin-ezetimibe combinations?
Clinical trials provide efficacy and safety evidence, underpin regulatory approvals, and reassure clinicians and patients, thereby accelerating adoption and reimbursement decisions.

2. Are there notable safety concerns with long-term use of atorvastatin-ezetimibe?
Long-term data suggest favorable safety profiles, although some concerns remain over rare adverse effects like myopathy or hepatic dysfunction, warranting ongoing surveillance.

3. What patient populations benefit most from such combination therapy?
High-risk patients with established CVD, those unable to tolerate high-dose statins, and individuals with familial hypercholesterolemia benefit significantly.

4. How might patent expirations affect the market dynamics?
Patent expirations open avenues for generics, reducing prices and increasing accessibility but intensify competition for brand-name manufacturers.

5. What role does technological innovation play in future market growth?
Advancements in drug delivery, personalized medicine, and digital health integration will enhance adherence, efficacy, and market reach, positioning companies favorably.


References

[1] Market Research Future. "Hyperlipidemia Management Market Report," 2022.

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