[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, three-sequence, three-period partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in healthy Chinese adult subjects

主要目的：考察空腹/餐后单次口服受试制剂氨氯地平阿托伐他汀钙片（规格：5 mg/20 mg（以氨氯地平/阿托伐他汀计），安徽佳和药业有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（多达一®，规格：5 mg/20 mg（以氨氯地平/阿托伐他汀计），Pfizer Manufacturing Deutschland GmbH生产），在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main purpose: To investigate the relative bioavailability of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Anhui Jiahe Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (DaDaYi®, specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Pfizer Manufacturing Deutschland GmbH) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary purpose: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

Start Date25 Oct 2024

Sponsor / Collaborator

Anhui Jiahe Pharmaceutical Co., Ltd.

CTR20243396

/ CompletedNot Applicable

健康受试者空腹和餐后单次口服氨氯地平阿托伐他汀钙片的随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉设计生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover design bioequivalence study of a single oral dose of amlodipine and atorvastatin calcium tablets in healthy subjects on an empty stomach or after a meal.

主要目的：研究空腹和餐后状态下单次口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg /10mg，安徽肽渡生物医药科技有限公司持证，裕松源药业有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（多达一®，规格：5mg/10mg，Pfizer Manufacturing Deutschland GmbH生产）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要目的：空腹和餐后状态下，研究单次口服受试制剂氨氯地平阿托伐他汀钙片和参比制剂氨氯地平阿托伐他汀钙片（多达一®）在健康成年受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5mg/10mg, licensed by Anhui Peptide Biotechnology Co., Ltd., produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®, specifications: 5mg/10mg, produced by Pfizer Manufacturing Deutschland GmbH) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To study the safety of the test preparation amlodipine atorvastatin calcium tablets and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®) in healthy adult subjects in the fasting and fed state.

Start Date05 Oct 2024

Sponsor / Collaborator

An Hui Tai Du Sheng Wu Yi Yao Ke Ji You Xian Gong Si

CTR20241265

/ CompletedNot Applicable

氨氯地平阿托伐他汀钙片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、三序列、三周期、部分重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in Chinese healthy volunteers under fasting and fed conditions

按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对翎耀生物科技（上海）有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) with Pharmacia and Upjohn Co LLC as the licensee were selected as the reference preparation, and the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) provided by Lingyao Biotechnology (Shanghai) Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed administration conditions.

Start Date20 May 2024

Sponsor / Collaborator

Lingyao Biotechnology (Shanghai) Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Atorvastatin Calcium

100 Translational Medicine associated with Amlodipine Besylate/Atorvastatin Calcium

100 Patents (Medical) associated with Amlodipine Besylate/Atorvastatin Calcium

Literatures (Medical) associated with Amlodipine Besylate/Atorvastatin Calcium

01 Dec 2014·BMC ophthalmologyQ4 · MEDICINE

Chronic unilateral chemosis following the use of amlodipine besylate

Q4 · MEDICINE

ArticleOA

Author: Wan Soo Kim ; Kyeong Hwan Kim

BACKGROUND:

This case report describes a patient with chronic unilateral chemosis, likely due to treatment with amlodipine besylate.

CASE PRESENTATION:

A 52-year-old man visited the clinic with symptoms of foreign body sensation and puffiness in his right eye, which had persisted for 4 months. There were no other symptoms, such as itching and pain, in his right eye and no specific symptoms in his left eye. He had been treated for hypertension and hyperlipidemia for the previous 5 months with once daily amlodipine besylate/atorvastatin (Caduet) and candesartan cilexetil (Atacand). Examination revealed marked swelling of the inferior bulbar conjunctiva in the right eye. Evaluation revealed no specific causes for the longstanding chemosis. A change of medication to telmisartan/hydrochlorothiazide (Micardis Plus) without amlodipine besylate resulted in significant improvements in his symptoms after 1 month and complete remission after 8 months.

CONCLUSION:

Prior to invasive evaluation including biopsy, specific drugs should be considered as possible causes of idiopathic longstanding conjunctival chemosis.

01 Jan 2013·Analytical chemistry insights

Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Binary Mixture by Spectrofluorimetry and HPLC Coupled with Fluorescence Detection

Article

Author: Ahmed, Maha S. ; Mahrouse, Marianne A. ; Moussa, Bahia A. ; El-Zaher, Asmaa A.

Caduet tablets are novel prescription drug that combines amlodipine besylate (AM) with atorvastatin calcium (AT). A spectrofluorimetric and an HPLC-fluorescence detection methods were developed for simultaneous determination of both drugs in tablets. In the spectrofluorimetric method, native fluorescence of AM and AT were measured in methanol at 442 and 369 nm upon excitation at 361 and 274 nm, respectively. The emission spectrum of each drug reveals zero value at the emission wavelength of the other drug, thus allowing their simultaneous determination without interference. In the HPLC method, separation of AM and AT was achieved within 8 minutes on a C18column using acetonitrile:phosphate buffer (0.015 M, pH 3) (45:55, v/v) as the mobile phase. Fluorescence detection was carried out using excitation wavelengths 361 and 274 nm and emission wavelengths 442 and 378 nm for AM and AT, respectively. Excellent linearity was observed. Careful validation proved advantages of the new methods: high sensitivity, accuracy, selectivity and suitability for quality control laboratories.

01 Jan 2013·Advances in therapyQ3 · MEDICINE

Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (The STRONG DUET Study)

Q3 · MEDICINE

Article

Author: Jan Fedacko ; Lucia Merkovska ; Peter Jarcuska ; Martin Janicko ; Matej Sajty ; Tomas Lopuchovsky ; Lucia Jedlickova ; Jan Kmec ; Daniel Pella ; Frantisek Sabol

INTRODUCTION:

The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.

METHODS:

This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.

RESULTS:

Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.

CONCLUSION:

Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.

News (Medical) associated with Amlodipine Besylate/Atorvastatin Calcium

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

10 Dec 2015

·www.daiichisankyo.com

Daiichi Sankyo Launches New Generic Drugs Through its Daiichi Sankyo Espha Subsidiary

PDF (277KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Executive Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com/ Tokyo, Japan (December 10, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that its generics subsidiary, Daiichi Sankyo Espha, is launching fourteen new generic drugs with six new active ingredients on Friday, December 11, as well as two new generic drugs with one new active ingredient in March 2016. Overview 1. Product names/therapeutic categories 1) Products launched on December 11, 2015 Product name Therapeutic category Original brand name Sertraline Tablets 25mg “DSEP” Selective serotonin Re-uptake inhibitor JZOLOFT® Tablets 25mg, 50mg Sertraline Tablets 50mg “DSEP” AMVALO® Combination Tablets “DSEP” Selective AT1 receptor blocker/prolonged Ca antagonist combination EXFORGE® Combination Tablets AMALUET® Combination Tablets 1Ban “DSEP” Prolonged Ca antagonist/ HMG-CoA reductase inhibitor Caduet® Combination Tablets 1Ban, 2Ban, 3Ban, 4Ban AMALUET ® Combination Tablets 2Ban “DSEP” AMALUET ® Combination Tablets 3Ban “DSEP” AMALUET ® Combination Tablets 4Ban “DSEP” TAZOPIPE® Combination I.V. Solution 2.25 “DSEP” β-lactamse inhibitor combination Antibiotic agent ZOSYN® I.V. 2.25, 4.5 ZOSYN® I.V. Bag 4.5 TAZOPIPE® Combination I.V. Solution 4.5 “DSEP” TAZOPIPE® Combination Drip I.V. Bag 2.25 “DSEP” TAZOPIPE® Combination Drip I.V. Bag 4.5 “DSEP” Rebamipide Tablets 100mg “DSEP” Treatment for gastritis/stomach ulcer Mucosta® Tablets 100mg Tamsulosin Hydrochloride OD Tablets 0.1mg “KN” Treatment for urination disorder due to enlargement of prostate Harnal® D Tablets 0.1mg, 0.2mg Tamsulosin Hydrochloride OD Tablets 0.1mg “KN” *Joint launch with Kobayashi Kako * Regarding the TAZOPIPE formulation, in addition to initial indication (septicemia, pneumonia, pyelonephritis, cystitis), it has already received approval with one change (additional indication: febrile neutropenia (adults)) on November 25, 2015. 2) Products launched in March 2016 Product name Therapeutic category Original brand name CAMSHIA® Combination LD “SANDOZ” Prolonged angiotensin II receptor antagonist/prolonged Ca antagonist combination UNISIA® Combination Tablets LD, HD CAMSHIA® Combination HD “SANDOZ” 　　　　　　*Joint launch with Sandoz 2. Product attributes – Daiichi Sankyo Espha measures Daiichi Sankyo Espha has continued to maintain a level of quality based on the quality management standards of the Daiichi Sankyo Group. Thanks to initiatives such as the world’s first double-sided laser printing on tablets, Daiichi Sankyo Espha has contributed to innovations in formulations and labeling to make drugs easier to ingest and harder for patients to mistakenly take. These kinds of high value-added generic drugs are proposed as “premium generics.” Innovation of PTP sheets and tablets In order to prevent mistaken taking and ingestion, innovations in formulations and labeling are continuing to be developed. - Easily recognizable original symbols PTP sheets feature original symbol marks based on characteristics of formulations and diseases. - GS1 data barcode for each PTP sheet and packaging (outer box): With the aim of helping to ensure no mistaken taking of tablets, GS1 data barcodes are printed on the back of PTP sheets. Also, for the GS1 data barcodes on the packaging (outer box), in addition to fixed information (product name, dosage, etc.), varying information (manufacture lot No., efficacy period, etc.) can also be checked. - Pitch control: Clear identification by printing of product names, active ingredients, etc. in fixed positions on each tablet of the PTP sheets. - Double-sided printing (Sertraline Tablets, AMVALO Combination Tablets, AMALUET Combination Tablets, Tamsulosin Hydrochloride OD Tablets, CAMSHIA Combination Tablets): Printing of product name etc. on both sides of tablets to make them easier to distinguish. Other formulation and packaging innovations - The TAZOPIPE® Combination Drip I.V. Bag, holds a volume of solution (2.25 standard) that is not available in previous products and suitable for use on child patients who weight less, with waste reduction in mind. About Daiichi Sankyo Espha Daiichi Sankyo Espha is a company that manufactures and markets generic drugs, accommodating rising demand based on the spirit of Daiichi Sankyo Group corporate philosophy* of supplying pharmaceuticals to address diverse medical needs. Daiichi Sankyo Espha strives to provide peace of mind for users by fulfilling the most important pharmaceutical criteria of quality, information, and stable supply while delivering the economic benefits of generics. *Daiichi Sankyo Group corporate philosophy: To contribute to the enrichment of life around the world through the creation of innovative pharmaceuticals, and through the provision of pharmaceuticals addressing diverse medical needs. Daiichi Sankyo Espha Company Overview Company name: Daiichi Sankyo Espha Co., Ltd. Established: April 1, 2010 Business: Manufacture and sale of pharmaceuticals Capital: 450 million yen Representative: President Hiroto Yoshikawa Headquarters: 3-5-1, Nihonbashi, Honcho, Chuo-ku, Tokyo

Drug Approval

08 Jul 2011

·www.astellas.com

Pfizer and Astellas Announce the Transfer of Distribution Rightsfor Caduet® Combination Tablets to Astellas

Pfizer Japan Inc. (hereafter: Pfizer, Headquarters: Tokyo, President: Ichiro Umeda) and Astellas Pharma Inc. (hereafter: Astellas, Headquarters: Tokyo, President: Yoshihiko Hatanaka) today announced that the companies have reached the change of the co-promotion agreement for a combination drug of hypertension treatment and hypercholesterolemia treatment Caduet® Combination Tablets (generic name: amlodipine besylate and atorvastatin calcium), for which Pfizer holds the marketing approval rights in Japan, effective on October 1st, 2011. In August 2009, Pfizer and Astellas had reached a co-promotion agreement for Caduet Combination Tablets, and since its launch in December 2009 in Japan, both companies conduct the co-promotion activity. Pursuant to new agreement, Astellas will hold its distribution rights and book its sales which are currently booked by Pfizer from October 1st 2011. And, Pfizer will continue to conduct the co-promotion activity with Astellas. The impact from this agreement on Astellas’s financial forecast on the current fiscal year (from April 1, 2011 to March 31, 2012) will be immaterial. Caduet Combination Tablets is an oral combination drug of a hypertension treatment Norbasc® Tablets (generic name: amlodipine besylate) sold by Pfizer and a hypercholesterolemia treatment Lipitor® Tablets (generic name: atorvastatin calcium) co-promoted by Pfizer and Astellas. Caduet Combination Tablets is a single tablet to combine the most prescribed drugs for hypertension and hypercholesterolemia to help with both treatments and it is expected to improve medication adherence. Pfizer and Astellas have established great partnership through co-promotion of Lipitor Tablets and Caduet Combination Tablets. Pursuant to new agreement, Astellas will enhance its promotion activity to maximize the product value of Caduet Combination Tablets. Besides, both companies will further contribute to hypertension and hypercholesterolemia treatment by both products.

License out/inDrug Approval

100 Deals associated with Amlodipine Besylate/Atorvastatin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine Besylate/Atorvastatin Calcium	C10BX03	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypercholesterolemia, Familial	Japan	Viatris Pharmaceuticals Co., Ltd.	07 Jul 2009
Angina Pectoris	China	Pfizer Inc.	03 Apr 2008
Coronary Disease	China	Pfizer Inc.	03 Apr 2008
Hyperlipidemias	China	Pfizer Inc.	03 Apr 2008
Hypercholesterolemia	China	Pfizer Inc.	19 Apr 2005
Angina Pectoris, Variant	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Angina, Stable	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Dyslipidemias	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Heterozygous familial hypercholesterolemia	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Homozygous familial hypercholesterolemia	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hyperlipoproteinemia Type III	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hypertension	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hypertriglyceridemia	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004
Primary hypercholesterolemia	United States	Pharmacia & Upjohn, Inc.	30 Jan 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyper LDL cholesterolaemia	Phase 3	Japan	Viatris, Inc.	01 Sep 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01190007 (CTgov)	Phase 4	Angina Pectoris \| Hypertension \| Hypercholesterolemia	159	Caduet	dmornemlsh = yajtrgpvud jgmatqkjan (ovhjxdkdoz, uvnhuvnpum - rmuedvmcog) View more	-	03 Dec 2012
NCT00407537 (CRUCIAL, CTgov)	Phase 4	Hypertension \| Hypercholesterolemia	1,531	Amlodipine besylate/atorvastatin calcium single pill combination	ctgsjnjtgt(yficwbzgmz) = jggnsglshi ayengfubix (bpqpajbdhc, 8.26) View more	-	11 Nov 2011
NCT00412113 (TOGETHER, CTgov)	Phase 4	Dyslipidemias \| Hypertension	245	placebo+Norvasc (amlodipine)+Caduet (Norvasc + TLC)	uhxxbkyonh = tupdkpzctc qihkavgdhq (zumcgwnlar, svmkaahaaq - slwenqfraa) View more	-	06 Nov 2009
NCT00412113 (TOGETHER, CTgov)	Phase 4	Dyslipidemias \| Hypertension	245	Norvasc placebo+atorvastatin calcium+TLC+amlodipine besylate (Caduet + TLC)	uhxxbkyonh = uwxforputu qihkavgdhq (zumcgwnlar, gjknndhprg - eyoyiksvdz) View more	-	06 Nov 2009
NCT00174304 \| NCT00330785 (JEWEL programme, Pubmed \| Eur J Cardiovasc Prev Rehabil)	Not Applicable	Dyslipidemias \| Hyperlipidemias \| Hypertension	2,245	Single-pill amlodipine/atorvastatin	tbdhmxgsdm(rlhzyzpqxt) = dotgfrjwzh tjryjqgecm (bmgfocukso )	-	01 Aug 2009
NCT00530946 (CTgov)	Phase 3	Hyper LDL cholesterolaemia \| Hypertension	165	CI-1038 (CI-1038 2.5 mg/5 mg)	njorvxmlos(tjfoatxqno) = rnpyjvlaak lbjnrxvixm (sqgthyfzma, 1.65) View more	-	13 Apr 2009
NCT00530946 (CTgov)	Phase 3	Hyper LDL cholesterolaemia \| Hypertension	165	CI-1038 (CI-1038 2.5 mg/10 mg)	njorvxmlos(tjfoatxqno) = oifzampcvc lbjnrxvixm (sqgthyfzma, 1.69) View more	-	13 Apr 2009

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