Delving into the Latest Updates on Hydrochlorothiazide/Telmisartan with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

TELMISARTAN/HYDROCHLOROTHIAZIDE, Telmisartan and Hydrochlorothiazide, Telmisartan/Hydrochlorothiazide

+ [14]

Target

AT1R x NCC

Action

antagonists, inhibitors

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Essential HypertensionHypertension

Inactive Indication-

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization

Boehringer Ingelheim International GmbH

Daiichi Sankyo Co., Ltd.Boehringer Ingelheim Pty Ltd.

+ [6]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (17 Nov 2000),

Hypertension

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC40H38ClN7O6S2

InChIKeyOZCVMXDGSSXWFT-UHFFFAOYSA-N

CAS Registry485391-74-0

南京黄龙生物科技有限公司研制的替米沙坦氢氯噻嗪片（80mg/12.5mg）与Boehringer Ingelheim International GmbH上市的替米沙坦氢氯噻嗪片（美嘉素®，80mg/12.5mg）在中国健康受试者中进行的随机、开放、单剂量、2序列、4周期、交叉、空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, 2-sequence, 4-period, crossover, fasting and fed bioequivalence study of telmisartan hydrochlorothiazide tablets (80 mg/12.5 mg) developed by Nanjing Huanglong Biotechnology Co., Ltd. and telmisartan hydrochlorothiazide tablets (Mekasu®, 80 mg/12.5 mg) marketed by Boehringer Ingelheim International GmbH in healthy Chinese subjects

以南京黄龙生物科技有限公司研制的替米沙坦氢氯噻嗪片（规格：80mg/12.5mg）为受试制剂，以Boehringer Ingelheim International GmbH公司上市的替米沙坦氢氯噻嗪片（美嘉素 ®，规格：80mg/12.5mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Telmisartan hydrochlorothiazide tablets (specification: 80mg/12.5mg) developed by Nanjing Huanglong Biotechnology Co., Ltd. were used as the test preparation, and Telmisartan hydrochlorothiazide tablets (Mekasu ®, specification: 80mg/12.5mg) marketed by Boehringer Ingelheim International GmbH were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date15 Aug 2024

Sponsor / Collaborator

Nanjing Huanglong Biotechnology Co. Ltd.

CTR20242468

/ CompletedNot Applicable

替米沙坦氢氯噻嗪片（40 mg/12.5 mg）在健康受试者中空腹/餐后生物等效性试验

[Translation] Fasting/fed bioequivalence study of telmisartan hydrochlorothiazide tablets (40 mg/12.5 mg) in healthy subjects

主要目的：在健康男性与女性受试者中于空腹/餐后条件下，评价受试制剂替米沙坦氢氯噻嗪片（规格：40 mg/12.5 mg，生产商：浙江华海药业股份有限公司）和Boehringer Ingelheim为持证商的参比制剂替米沙坦氢氯噻嗪片（MICARDIS HCT，规格：40 mg/12.5 mg）的生物等效性。次要目的：观察受试制剂替米沙坦氢氯噻嗪片与参比制剂替米沙坦氢氯噻嗪片（MICARDIS HCT）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation Telmisartan Hydrochlorothiazide Tablets (Specifications: 40 mg/12.5 mg, Manufacturer: Zhejiang Huahai Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Hydrochlorothiazide Tablets (MICARDIS HCT, Specifications: 40 mg/12.5 mg) of which Boehringer Ingelheim is the licensee in healthy male and female subjects under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation Telmisartan Hydrochlorothiazide Tablets and the reference preparation Telmisartan Hydrochlorothiazide Tablets (MICARDIS HCT) in healthy subjects.

Start Date06 Aug 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTIS2023-504812-13-00

/ RecruitingNot ApplicableIIT

Effects of single-pill combination of telmisartan/amlodipine and telmisartan/amlodipine/hydrochlorothiazide on 24-hour blood pressure (BP) reduction, 24-h BP variability and office BP control in patients with arterial hypertension – SATELLITE - KCT02/2023-SATELLITE

Start Date06 May 2024

Sponsor / Collaborator

KRKA TOVARNA ZDRAVIL DD NOVO MESTO

100 Clinical Results associated with Hydrochlorothiazide/Telmisartan

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100 Translational Medicine associated with Hydrochlorothiazide/Telmisartan

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100 Patents (Medical) associated with Hydrochlorothiazide/Telmisartan

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24

Literatures (Medical) associated with Hydrochlorothiazide/Telmisartan

20 Jan 2014·Journal of Liquid Chromatography & Related Technologies

QUANTITATIVE DETERMINATION OF FOUR ANGIOTENSIN-II-RECEPTOR ANTAGONISTS IN PRESENCE OF HYDROCHLOROTHIAZIDE BY A GRADIENT TECHNIQUE HPLC IN THEIR PHARMACEUTICAL PREPARATIONS

Author: Elshanawane, Abdullah A. ; Abdelaziz, Lobna M. ; Hafez, Hani M. ; Kamal, Magda M.

Losartan potassium, Valsartan, Telmisartan, and Irbesartan are angiotensin-II-receptor antagonists (ARA II) group, which used in treatment of hypertension alone or in combination with other drugs mainly Hydrochlorothiazide.A gradient HPLC method was developed for the assay of several ARAII in presence of Hydrochlorothiazide.The method was performed by reversed phase high performance liquid chromatog. using a mobile phase 0.025 M potassium dihydrogen phosphate (pH 6.0): acetonitrile = 80:20% with detection at 220 nm on an ACE C18 column (250 mm × 4.6 mm, 5 μm) at flow rate 1.5 mL/min in a gradient manner.The proposed method was validated in terms of linearity, accuracy, precision, and limits of detection and quantitation.

01 Jul 2013·American Journal of HypertensionQ3 · MEDICINE

Dynamic View on Affordability of Fixed-Dose Combination Antihypertensive Drug Therapy

Q3 · MEDICINE

Article

Author: Junling Wang ; Song Hee Hong ; Jun Tang

BACKGROUNDThe use of fixed-dose combinations (FDCs) has been increasing since the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommended using ≥2 drugs as the first-line drug therapy for patients with stage 2 hypertension. FDCs simplify the drug therapy regimen and reportedly lower the drug therapy cost compared with the free combination (FC) of 2 single-agent drugs. This study hypothesized that the affordability of FDCs over FCs would change over time depending on the availability of generic single-agent drugs.METHODSThis study used the 2009 Medical Expenditure Panel Survey. Antihypertensive drugs were identified based on the Food and Drug Administration national drug directory. Based on the 2 databases, regression models were run to predict average monthly drug cost as well as out-of-pocket cost for each prescription along with their 95% confidence intervals (CIs).RESULTSOverall, FDCs (n = 26) had average monthly drug costs similar to respective FCs when FCs were not generically available. However, when FCs were generically available, FDCs (n = 11) had average drugs costs much higher than their respective FCs. For example, Lotrel as an FDC had an average monthly drug cost of $115.97 (95% CI = $96.59-$135.36), whereas its counterpart FC had an average monthly drug cost of $21.00 (95% CI = $18.23-$23.79).CONCLUSIONSThe cost advantage of FDCs over FCs was reversed when FCs were generically available. The finding of this study informs patients, health-care providers, and drug plans of the importance of making dynamic decisions on preferred drug therapy options depending on the availability of generic drugs.

01 Sep 2012·Journal of the Renin-Angiotensin-Aldosterone SystemQ4 · MEDICINE

Efficacy and safety of a single-pill fixed-dose combination of high-dose telmisartan/hydrochlorothiazide in patients with uncontrolled hypertension

Q4 · MEDICINE

ArticleOA

Author: Shirotani, Tetsuro ; Shimizu, Tomohiko ; Shiga, Yuhei ; Miura, Shin-ichiro ; Inoue, Asao ; Morii, Joji ; Saku, Keijiro ; Matsunaga, Eiyu ; Norimatsu, Kenji ; Arimura, Tadaaki ; Mitsutake, Ryoko ; Uehara, Yoshinari ; Nagata, Itsuki ; Fujisawa, Kazuaki ; Kuwano, Takashi

Objective: Many patients still have high blood pressure (BP) after treatment with high-dose angiotensin II type 1 receptor blockers (ARBs) or Preminent® (medium-dose of losartan (50 mg/day)/hydrochlorothiazide (HCTZ) (12.5 mg/day)). Therefore, we analyzed whether Micombi®BP (high-dose telmisartan (80 mg/day)/HCTZ (12.5 mg/day)) could provide better results with regard to efficacy and safety for patients with uncontrolled hypertension. Methods: In total, 44 hypertensive patients (22 males, age 71±14 years) who showed uncontrolled BP despite the use of high-dose ARBs or Preminent® were enrolled in this study. We used a changeover design in which the patients were switched from high-dose ARBs or Preminent® to Micombi®BP. We analyzed BP, heart rate (HR), and biochemical parameters before and after treatment for 3 months. Results: Systolic BP and diastolic BP significantly decreased (125±15/69±11 mmHg) and 85% of the patients achieved their target BP at 3 months after changeover. Patients who switched from ARBs and those who switched from Preminent® showed similar BP-lowering effects. In addition, the reductions in BP after 3 months in patients with or without chronic kidney disease and in those with or without metabolic syndrome (MetS) were also similar. There were no significant changes in HR during the study period. Although blood levels of potassium, hemoglobin A1c and uric acid (UA) significantly increased after 3 months for all of the patients, none of the patients showed serious adverse effects. Conclusion: High-dose telmisartan/HCTZ therapy was associated with a significant reduction in BP and helped patients achieve their target BP.

100 Deals associated with Hydrochlorothiazide/Telmisartan

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	European Union	Bayer AG	19 Apr 2002
Essential Hypertension	Iceland	Bayer AG	19 Apr 2002
Essential Hypertension	Liechtenstein	Boehringer Ingelheim International GmbH	19 Apr 2002
Essential Hypertension	Liechtenstein	Bayer AG	19 Apr 2002
Essential Hypertension	European Union	Boehringer Ingelheim International GmbH	19 Apr 2002
Essential Hypertension	Iceland	Boehringer Ingelheim International GmbH	19 Apr 2002
Essential Hypertension	Norway	Boehringer Ingelheim International GmbH	19 Apr 2002
Essential Hypertension	Norway	Bayer AG	19 Apr 2002
Hypertension	United States	Boehringer Ingelheim GmbH	17 Nov 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Preclinical	Japan	Boehringer Ingelheim GmbH	01 Jan 2005
Hypertension	Preclinical	-	Boehringer Ingelheim GmbH	01 Feb 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01911780 (CTgov)	Phase 3	Hypertension	132	amlodipine+telmisartan + HCTZ (Telmisartan + HCTZ + Amlodipine)	bnbdadwseg(qvvwehtbga) = eqwfqrboxf oozawdvxar (xhptenjqny, mgfiptimkg - jqutedpesn) View more	-	28 Mar 2016
				placebo+telmisartan + HCTZ (Telmisartan + HCTZ + Placebo)	bnbdadwseg(qvvwehtbga) = vxpwypnpym oozawdvxar (xhptenjqny, kfgegpbroj - irtbvrctgf) View more
PP.5.215 (ESH2010)	Not Applicable	Metabolic Syndrome \| Hypertension	60	Telmisartan 80mg/Hydrochlorothiazide 12.5mg	(atfjuldgpj) = ipjorbbzng jnewdzyyof (nectykcrwy ) View more	Positive	01 Jun 2010
				Telmisartan 40mg	(atfjuldgpj) = eievctolho jnewdzyyof (nectykcrwy ) View more
NCT00267943 (Pubmed \| Expert Opin Pharmacother)	Phase 3	-	639	Telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination	slbnbzomwi(ejvjukobqd) = occurred in 29 (4.5%) patients yikgrvfvak (mazppdunrj )	-	01 Feb 2009