US 20030199492A1
· Scott
· 2003
[cited by applicant]
US 20040198789A1
· Leonardi et al.
· 2004
[cited by applicant]
US 20050187262A1
· Grogan et al.
· 2005
[cited by applicant]
US 20070191438A1
· Rohrer
· 2007
[cited by applicant]
US 20070293552A1
· Gorczynski
· 2007
[cited by applicant]
US 20080096866A1
· Woo et al.
· 2008
[cited by applicant]
US 20120115854A1
· Shetty et al.
· 2012
[cited by applicant]
US 20200030296A1
· Rodgers et al.
· 2020
[cited by applicant]
US 20230125076A1
· Rodgers et al.
· 2023
[cited by applicant]
CA 3107616A1
· 2020
[cited by examiner]
CN 101450211A
· 2009
[cited by applicant]
CN 101618215A
· 2010
[cited by applicant]
CN 101966187A
· 2011
[cited by applicant]
CN 101966190A
· 2011
[cited by applicant]
CN 102225203A
· 2011
[cited by applicant]
CN 102327272B
· 2013
[cited by applicant]
CN 106310278A
· 2017
[cited by applicant]
EP 1272220B1
· 2006
[cited by applicant]
EP 2575808A1
· 2013
[cited by applicant]
JP 2010209123A
· 2010
[cited by applicant]
KR 20090057538A
· 2009
[cited by applicant]
WO WO03097045A1
· 2003
[cited by applicant]
WO WO2007098390A2
· 2007
[cited by applicant]
WO WO2007109037A2
· 2007
[cited by applicant]
WO WO2007146900A2
· 2007
[cited by applicant]
WO WO2009026517A2
· 2009
[cited by applicant]
WO WO2010127099A2
· 2010
[cited by applicant]
WO WO2011149438A1
· 2011
[cited by applicant]
WO WO2014114627A1
· 2014
[cited by applicant]
WO WO2017054787A1
· 2017
[cited by applicant]
WO WO2018091967A1
· 2018
[cited by applicant]
WO WO2018138578A1
· 2018
[cited by applicant]
WO WO2020021341A1
· 2020
[cited by applicant]
CN 102869360—English—2011 (Year: 2011).
[cited by examiner]
Amlodipine Besylate Tablets. Greenstone Brand. NDS 19-787/S-042 (14 pgs) (2007).
[cited by applicant]
Andren et al. Enalapril with either a “very low” or “low” dose of hydrochlorothiazide is equally effective in essential hypertension: a double-blind trial in 100 hypertensive patients. J Hypertension I(suppl2):384-386 (…
[cited by applicant]
Anonymous. Assessment Report for Exforge HCT. European Medicines Agency. Evaluation of Medicines for Humane Use. Retrieved from the Internet: URL: https://www.ema.europa.eu/en/documents/assessment-report/exforge-hct-epa…
[cited by applicant]
Anonymous. Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial. clinicaltrials.gov (Mar. 4, 2016). Retrieved from the Internet: URL:https://clinicaltrials.gov/ct2/show/record/NCT02699645?view=recor…
[cited by applicant]
Australian Institute of Health and Welfare 2017. Medicines for cardiovascular disease. Cat. No. CVD 80. Canberra: AIHW box 4 (36 pgs.) (2017).
[cited by applicant]
Beall et al. Could patents interfere with the development of a cardiovascular polypill? J Transl Med 14:242 (2016).
[cited by applicant]
Berge et al. Pharmaceutical Salts. Journal of Pharmaceutical Sciences 66(1):1-19 (Jan. 1977).
[cited by applicant]
Bisoprolol/hydrochlorothiazide (Rx). Medscape Drugs & Diseases. Available at https://reference.medscape.com/drug/ziac-bisoprolol-hydrochlorothiazide-999421 (retrieved Dec. 18, 2020).
[cited by applicant]
ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin. [retrieved from internet on Nov. 11, 2019] URL:<https://clinicaltrials.gov/ct2/show/NCT03088254> First Posted Mar. 23…
[cited by applicant]
ClinicalTrials.gov. The SCCS Polypill Pilot Trial. [retrieved from internet on Nov. 19, 2019] URL: ″>https://clinicaltrials.gov/ct2/show/NCT02278471; First Posted Oct. 30, 2014.
[cited by applicant]
ClinicalTrials.gov. Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT). [retrieved from internet on Apr. 12, 2018] URL: ″>https://clinicaltrials.gov/ct2/show/results/NCT02699645; First p…
[cited by applicant]
CRESTOR (rosuvastatin calcium) tablets drug label. Initial U.S. Approval: 2003. Reference ID: 3937746. May 2016.
[cited by applicant]
Diabetes Educational Services. Available at https://diabetesed.net/page/_files/Antihypertensive-Meds-2012.pdf (3 pgs.) (2012).
[cited by applicant]
Dinicolantonio et al. Evidence-based diuretics: focus on chlorthalidone and indapamide . Future Cardiology 11:203-217 (2015).
[cited by applicant]
Drug Dosage. https://www.drugs.com/dosage/ (3 pgs.) (Accessed Apr. 2018).
[cited by applicant]
Emc+ Compendium. Latest Medicine Updates. https://www.medicines.org.uk/emc (2 pgs.) (Accessed Apr. 2018).
[cited by applicant]
Fishbane et al. Iron deficiency in non-dialysis chronic kidney disease. Kidney Int 75:752-754 (2008).
[cited by applicant]
Fletcher et al. Efficacy of drug therapy in the secondary prevention of cardiovascular disease and stroke. Am J Cardiol. 99(6C):1E-35E (2007).
[cited by applicant]
Glezer et al. Comparative analysis of the effectiveness of diuretic in the treatment of arterial hypertension in women. The results of the Athena study. Problems of Women's Health 2(4):5-16 (2009).
[cited by applicant]
Higaki et al. Effect of hydrochlorothiazide in addition to telmisartan/amlodipine combination for treating hypertensive patients uncontrolled with telmisartan/amlodipine: a randomized, double-blind study. Hypertens Res …
[cited by applicant]
Huffman et al. Low-Dose Combination Blood Pressure Pharmacotherapy to Improve Treatment Effectiveness, Safety and Efficiency. JAMA 320(6):552-554 (2018).
[cited by applicant]
Huo et al. Effect of Simvastatin on Ankle Brachial Index in Middle and Old Age Patients with Hypertension. China Pharmacy 24(40):3795-3796 (2013) (English Abstract).
[cited by applicant]
Jadhav et al. Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study. PLoS One 9(4):e92955 (2014).
[cited by applicant]
Kenward et al. An improved approximation to the precision of fixed effects from restricted maximum likelihood. Computational Statistics & Data Analysis 53(7):2583-2595 (2009).
[cited by applicant]
Kenward et al. The use of baseline covariates in crossover studies. Biostatistics 11(1):1-17 (2010).
[cited by applicant]
Kharkevich. Pharmacology 3rd ed. Revised and supplemented, −M: Medicine p. 34 (1987).
[cited by applicant]
Kirichenko. The angiotensin II receptor antagonist candesartan in the arsenal of the therapist. Consilium Medicum 18:76-80 (2016).
[cited by applicant]
Krosnyuk et al. Pharmaceutical technology: Technology of dosage forms: textbook. for stud. higher. study institutions 2nd ed. stereo—M.: Publishing Center “Academia”. p. 6 (2006).
[cited by applicant]
Kuriyama et al. Renoprotective effect of triple therapy with low-dose angiotensis receptor blocker, low-dose diuretic and Ca-antagonist in hypertensive type-2 diabetic patients with overt nephropathy. Japanese Journal o…
[cited by applicant]
Law et al. Lowering blood pressure to prevent myocardial infarction and stroke: a new preventive strategy. Health Technology Assessment 7(31):1-105 (2003).
[cited by applicant]
Law et al. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 326(7404):1427 (2003).
[cited by applicant]
Lee et al. A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential …
[cited by applicant]
Liu et al. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med 28(20):2509-2530 (2009).
[cited by applicant]
Lozol® Indapamide Tablets. Aventis Pharmaceuticals Inc. (8 pgs.) (2005).
[cited by applicant]
Mahmud et al. Low-dose quadruple antihypertensive combination: more efficacious than individual agents—a preliminary report. Hypertension 49:272-275 (2007).
[cited by applicant]
Maladkar et al. Triple drug combination of telmisartan, amlodipine and hydrochlorothiazide in the treatment of essential hypertension. Open Journal of Internal Medicine 2:67-71 (2012).
[cited by applicant]
Mallion et al. ABPM comparison of the antihypertensive profiles of the selective angiotensin II receptor antagonists telmisartan and losartan in patients with mild-to-moderate hypertension. J Hum Hypertens 13:657-664 (1…
[cited by applicant]
Micardis (Telmisartan) Tablets. Boehringer Ingelheim. NDA 20-850/S-022/S-023 (12 pgs.) (2009).
[cited by applicant]
Morozova et al. Clinical and economic aspects of the use of statins in patients with arterial hypertension with lipid metabolism disorders. Quality Clinical Practice 3:66-70 (2008).
[cited by applicant]
Neutel et al. Comparison of Monotherapy with Irbesartan 150 mg or Amlodipine 5 mg for Treatment of Mild-to-Moderate Hypertension. J Renin-Angiotensin_Aldosteone System 6(2):84-89 (2005).
[cited by applicant]
Nickenig. Should Angiotensin II Receptor Blockers and Statins Be Combined? Circulation 10:1013-1020 (2004).
[cited by applicant]
O'Brien et al. Ambulatory Blood Pressure Measurement. What Is the International Consensus? Hypertension 62(6):988-994 (2013).
[cited by applicant]
Ohira et al. Comparisons of Increasing Calcium Channel Blocker dose and Adding Thiazide Diuretic in Hypertensive Patients Given Medium-dose Angiotensin II Receptor Blocker and Amlodipine. Dokkyo Journal of Medical Scien…
[cited by applicant]
PCT/IB2017/001524 International Search Report and Written Opinion dated Apr. 17, 2018.
[cited by applicant]
PCT/IB2018/000083 International Search Report and Written Opinion dated Apr. 24, 2018.
[cited by applicant]
PCT/IB2019/000923 International Search Report and Written Opinion dated Dec. 2, 2019.
[cited by applicant]
Pinto et al. Lessons from rat models of hypertension: from Goldblatt to genetic engineering. Cardiovascular Res 39(1):77-88 (1998).
[cited by applicant]
RxList. https://www.rxlist.com (5 pgs.) (Accessed Apr. 2018).
[cited by applicant]
Salam et al. TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol. Am Heart J. 167(2):127-132 (2014).
[cited by applicant]
Sharma. Dr. Reddy's launches combo drug for hypertension. Available at https://www.businesstoday.in/industry/pharma/story/dr-reddys-launches-combo-drug-for-hypertension-135017-2014-01-10 (2014).
[cited by applicant]
Shilov. III-generation calcium channel blockers in the treatment of arterial hypertension. Systemic hypertension 3:38-42 (2013).
[cited by applicant]
Skoularigis et al. Low dose hydrochlorothiazide (12.5 to 25 mg daily) as monotherapy in black patients with mild to moderate hypertension. Assessment by ambulatory blood pressure monitoring. Am J Hypertens 8(10 Pt 1):10…
[cited by applicant]
Smith et al. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Pressure Monitoring 8(3):111-117 (2003).
[cited by applicant]
Spinler et al. ACE inhibitors versus ARBs: comparison of practice guidelines and treatment selection considerations. Formulary 41:274-284 (2006).
[cited by applicant]
Sureja et al. Development and validation of HPTLC method for simultaneous estimation of telmisartan and indapamide in pharmaceutical solid dosage form. Journal of Chemical and Pharmaceutical Research 7:236-240 (2015).
[cited by applicant]
Tandon et al. Antihypertensive drug prescription patterns, rationality, and adherence to Joint National Committee-7 hypertension treatment guidelines among Indian postmenopausal women. J Mid-life Health 5(2):78--83 (201…
[cited by applicant]
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT). Available at https://clinicaltrials.gov/ct2/show/record/NCT02699645. First posted Mar. 4, 2016 (16 pgs).
[cited by applicant]
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT). Available at https://clinicaltrials.gov/ct2/show/record/NCT02699645. First posted Mar. 4, 2016 (Latest version Oct. 2, 2018) (9 pgs).
[cited by applicant]
U.S. Appl. No. 15/352,425 Office Action dated May 5, 2017.
[cited by applicant]
U.S. Appl. No. 15/352,425 Office Action dated Nov. 30, 2017.
[cited by applicant]
U.S. Appl. No. 15/919,923 Office Action dated Aug. 15, 2018.
[cited by applicant]
U.S. Appl. No. 15/919,923 Office Action dated Nov. 15, 2018.
[cited by applicant]
U.S. Appl. No. 16/393,774 Office Action dated Jan. 15, 2020.
[cited by applicant]
U.S. Appl. No. 16/523,230 Office Action dated Jan. 8, 2021.
[cited by applicant]
U.S. Appl. No. 16/523,230 Office Action dated Jun. 21, 2022.
[cited by applicant]
U.S. Appl. No. 16/523,230 Office Action dated Nov. 8, 2021.
[cited by applicant]
U.S. Appl. No. 17/014,358 Office Action dated Dec. 16, 2021.
[cited by applicant]
Volpe et al. Rationale for triple fixed-dose combination therapy with an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic. Vasc Health Risk Manag 8:371-380 (2012).
[cited by applicant]
Wald et al. Combination therapy versus monotherapy in reducing blood pressure: meta-analysis on 11,000 participants from 42 trials. Am J Med 122(3):290-300 (2009).
[cited by applicant]
Wald et al. Randomized Polypill crossover trial in people aged 50 and over. PLoS One 7(7):e41297 (2012).
[cited by applicant]
Webster et al. Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka: A Randomized Clinical Trial. JAMA 320(6)…
[cited by applicant]
Webster. Protocol changes to the TRIUMPH study. Am Heart J 191:e1 (2017).
[cited by applicant]
Chou. Drug Combination Studies and Their Synergy Quantification Using the Chou-Talalay Method. Cancer Res 70(2):440-446 (2010).
[cited by applicant]
Ershova A.K., Use of statins in patients with arterial hypertension. Russian Medical Journal 18(22):1389-1392 (2010).
[cited by applicant]
Mashkovsky M.D. Medicines: In 2 vols. V. 1.—M.: New Wave Publishing House LLC, 540:11 (2021).
[cited by applicant]
U.S. Appl. No. 17/932,982 Office Action dated Dec. 6, 2023.
[cited by applicant]
Vengerovsky, A.I. Pharmacological incompatibility. Bulletin of Siberian Medicine 3:49-56.
[cited by applicant]
Chrysant, Steven G. Single-pill triple-combination therapy: an alternative to multiple-drug treatment of hypertension. Postgrad Med 123(6):21-31 (2011).
[cited by applicant]