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Last Updated: March 28, 2025

CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM


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All Clinical Trials for amlodipine besylate; atorvastatin calcium

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Alphacait, LLC Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT02295046 ↗ Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition Completed Dr. Reddy's Laboratories Limited Phase 1 2011-10-01 This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in Healthy Male and Female Volunteers under Fasting conditions.
NCT02292069 ↗ Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition Completed Dr. Reddy's Laboratories Limited Phase 1 2011-09-01 This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in healthy, adult,human subjects under Fed conditions.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for amlodipine besylate; atorvastatin calcium

Condition Name

210-0.200.20.40.60.811.21.41.61.822.2HealthyMetastatic Cancer[disabled in preview]
Condition Name for amlodipine besylate; atorvastatin calcium
Intervention Trials
Healthy 2
Metastatic Cancer 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Neoplasm MetastasisMalnutrition[disabled in preview]
Condition MeSH for amlodipine besylate; atorvastatin calcium
Intervention Trials
Neoplasm Metastasis 1
Malnutrition 1
[disabled in preview] 0
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Clinical Trial Locations for amlodipine besylate; atorvastatin calcium

Trials by Country

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Trials by Country for amlodipine besylate; atorvastatin calcium
Location Trials
Germany 1
India 1
China 1
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Clinical Trial Progress for amlodipine besylate; atorvastatin calcium

Clinical Trial Phase

33.3%66.7%0-0.200.20.40.60.811.21.41.61.822.2Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for amlodipine besylate; atorvastatin calcium
Clinical Trial Phase Trials
Phase 2 1
Phase 1 2
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2CompletedUnknown status[disabled in preview]
Clinical Trial Status for amlodipine besylate; atorvastatin calcium
Clinical Trial Phase Trials
Completed 2
Unknown status 1
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Clinical Trial Sponsors for amlodipine besylate; atorvastatin calcium

Sponsor Name

trials000111112222Dr. Reddy's Laboratories LimitedAlphacait, LLCHaining Health-Coming Biotech Co., Ltd.[disabled in preview]
Sponsor Name for amlodipine besylate; atorvastatin calcium
Sponsor Trials
Dr. Reddy's Laboratories Limited 2
Alphacait, LLC 1
Haining Health-Coming Biotech Co., Ltd. 1
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Sponsor Type

50.0%50.0%0-0.200.20.40.60.811.21.41.61.822.2OtherIndustry[disabled in preview]
Sponsor Type for amlodipine besylate; atorvastatin calcium
Sponsor Trials
Other 2
Industry 2
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Clinical Trials, Market Analysis, and Projections for Amlodipine Besylate and Atorvastatin Calcium

Introduction to Amlodipine Besylate and Atorvastatin Calcium

Amlodipine besylate and atorvastatin calcium are two medications often combined in a single pill, known as Caduet, to treat hypertension and hyperlipidemia. Amlodipine besylate is a calcium channel blocker that lowers blood pressure, while atorvastatin calcium is a statin that reduces cholesterol levels.

Clinical Trials and Efficacy

Reduction in Cardiovascular Risk

Clinical trials have shown that the combination of amlodipine besylate and atorvastatin calcium is highly effective in reducing cardiovascular risk. The CRUCIAL trial demonstrated that Caduet significantly reduced the calculated 10-year risk of coronary heart disease (CHD) and fatal cardiovascular disease (CVD) based on the Framingham and SCORE risk assessment models, respectively[1].

Blood Pressure and Lipid Control

Numerous clinical trials have highlighted the efficacy of this combination in lowering blood pressure and low-density lipoprotein (LDL) cholesterol. The single-pill formulation has been shown to improve patients' achievement of national-guideline-recommended blood pressure and lipid target levels, with a safety profile consistent with its parent compounds[3].

Adverse Reactions and Precautions

While the combination is generally well-tolerated, there are some notable adverse reactions and precautions. For instance, the highest dose of atorvastatin (80mg) was associated with an increased risk of hemorrhagic stroke in patients with recent stroke or transient ischemic attack (TIA). Additionally, mild to moderate peripheral edema is a common adverse event, and liver function tests should be performed before and during treatment due to the risk of hepatic failure[4].

Market Analysis

Global Market Size and Growth

The global market for atorvastatin calcium was valued at $298.3 million in 2023 and is projected to reach $487.8 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2033. This growth is driven by the increasing prevalence of cardiovascular diseases and the expanding aging population[2].

Regional Market Outlook

North America currently holds the largest share of the atorvastatin calcium market due to the presence of major pharmaceutical companies, high prevalence of cardiovascular diseases, and well-established healthcare infrastructure. However, the Asia-Pacific region is expected to grow with the highest CAGR during the forecast period, driven by a rise in the target population and increasing health awareness[2].

Amlodipine Besylate Market

The global amlodipine besylate market was valued at $350 million in 2022 and is expected to grow at a CAGR of 4.5% from 2023 to 2030. This growth is attributed to the increasing cases of uncontrolled high blood pressure globally, particularly in the Asia-Pacific region where there is a surge in the geriatric population and enhanced accessibility of pharmaceutical products[5].

Market Segmentation

Atorvastatin Calcium Market Segmentation

The atorvastatin calcium market is segmented by form (tablets and others), application (hypercholesterolemia, hyperlipidemia, and others), distribution channel (hospital pharmacies, drug store & retail pharmacies, and online providers), and region (North America, Europe, Asia-Pacific, and LAMEA)[2].

Amlodipine Besylate Market Segmentation

The amlodipine besylate market is analyzed based on its worldwide presence in various regions, including North America, Europe, Asia-Pacific, and the Rest of the World. The market is also segmented based on the development of therapeutics and the presence of key generic pharmaceutical companies[5].

Competitive Landscape

Key Players

The atorvastatin calcium market is dominated by major pharmaceutical companies such as Mylan Pharmaceuticals Inc., Novartis AG, GlaxoSmithKline plc, Amgen Inc., Sanofi SA, Teva Pharmaceuticals Industries Ltd., Merck and Co., Bristol-Myers Squibb Company, AstraZeneca PLC, and Pfizer Inc.[2].

Recent Developments

Recent developments include the launch of new formulations, such as Norliqva, an amlodipine liquid solution for patients who have difficulty swallowing tablets. This innovation highlights the ongoing efforts to improve patient compliance and treatment outcomes[5].

Regional/Country Market Outlook

North America

North America remains a significant market for both amlodipine besylate and atorvastatin calcium due to the high prevalence of cardiovascular diseases and the presence of major pharmaceutical companies. The region is expected to continue its dominance, driven by advanced healthcare infrastructure and increasing awareness and diagnosis of cardiovascular conditions[2][5].

Asia-Pacific

The Asia-Pacific region is poised for rapid growth, driven by a rising geriatric population, increasing health awareness, and the presence of key generic pharmaceutical companies. This region offers lucrative opportunities for market expansion and is expected to grow with the highest CAGR during the forecast period[2][5].

Key Takeaways

  • Clinical Efficacy: The combination of amlodipine besylate and atorvastatin calcium significantly reduces cardiovascular risk and improves blood pressure and lipid control.
  • Market Growth: The global atorvastatin calcium market is projected to grow at a CAGR of 5% from 2024 to 2033, while the amlodipine besylate market is expected to grow at a CAGR of 4.5% from 2023 to 2030.
  • Regional Dominance: North America currently leads the market, but the Asia-Pacific region is expected to grow rapidly due to demographic and healthcare trends.
  • Competitive Landscape: Major pharmaceutical companies dominate the market, with ongoing innovations and launches of new formulations.

FAQs

What is the primary use of the combination of amlodipine besylate and atorvastatin calcium?

The primary use of this combination is to treat hypertension and hyperlipidemia, reducing the risk of cardiovascular events such as heart attacks, strokes, and angina.

Which regions are expected to drive the growth of the atorvastatin calcium market?

North America is currently the largest market, but the Asia-Pacific region is expected to grow with the highest CAGR during the forecast period due to a rising target population and increasing health awareness.

What are the common adverse reactions associated with the combination of amlodipine besylate and atorvastatin calcium?

Common adverse reactions include mild to moderate peripheral edema, increased risk of hemorrhagic stroke in patients with recent stroke or TIA, and potential liver function abnormalities.

Which companies are key players in the atorvastatin calcium market?

Major players include Mylan Pharmaceuticals Inc., Novartis AG, GlaxoSmithKline plc, Amgen Inc., Sanofi SA, Teva Pharmaceuticals Industries Ltd., Merck and Co., Bristol-Myers Squibb Company, AstraZeneca PLC, and Pfizer Inc.

What is the projected market size of the atorvastatin calcium market 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.

Sources

  1. Pfizer Press Release: "Caduet Reduces 10-Year Calculated Risk Of Coronary Heart Disease, Fatal Cardiovascular Disease" - June 20, 2010.
  2. Allied Market Research: "Atorvastatin Calcium Market Size, Share | Forecast - 2033".
  3. PubMed: "A single-pill combination of amlodipine besylate and atorvastatin calcium".
  4. Health Canada: "MYLAN-AMLODIPINE/ATORVASTATIN - Product Monograph".
  5. UnivDatos: "Amlodipine Besylate Market Current Analysis and Forecast (2023 - 2030)".

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