Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.

Start Date01 Dec 2024

Sponsor / Collaborator

EMS SA (Brazil)

CTR20221126 / CompletedNot Applicable

评估受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康成年受试者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Specifications: 20 mg/12.5 mg) and the reference preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Fuaotan®) (Specifications: 20 mg/12.5 mg) in healthy adult subjects in the fed state

主要试验目的：研究餐后状态下单次口服受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg，宁波美诺华天康药业有限公司生产）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®，规格：20 mg/12.5 mg；第一三共制药（上海）有限公司生产）在健康受试者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）和参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg, produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®, specification: 20 mg/12.5 mg; produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study: to study the safety of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®) (specification: 20 mg/12.5 mg) in healthy subjects.

Start Date11 Jun 2022

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

CTR20221127 / CompletedNot Applicable

评估受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

主要试验目的：研究空腹状态下单次口服受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg，宁波美诺华天康药业有限公司生产）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®，规格：20 mg/12.5 mg；第一三共制药（上海）有限公司生产）在健康受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）和参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg, produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®, specification: 20 mg/12.5 mg; produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary purpose of the study is to study the safety of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®) (specification: 20 mg/12.5 mg) in healthy subjects.

Start Date07 Jun 2022

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Olmesartan Medoxomil

100 Translational Medicine associated with Hydrochlorothiazide/Olmesartan Medoxomil

100 Patents (Medical) associated with Hydrochlorothiazide/Olmesartan Medoxomil

Literatures (Medical) associated with Hydrochlorothiazide/Olmesartan Medoxomil

01 Mar 2007·Revue medicale de Liege

[Medication of the month. Olmesartan medoxomil hydroclorothiazide (Olmetec Plus or Belsar Plus].

Review

Author: Lancellotti, P

The therapeutic control of hypertension is still a global challenge and frequently requires combination therapy. Olmesartan medoxomil hydrochlorothiazide (Olmetec plus, Belsar plus) is a fixed-dose combination of olmesartan 20 mg and hydrochlorothiazide 12.5 or 25 mg. Olmesartan is a well known angiotensin II AT1 receptor blocker characterized by a good efficacy, a fast and prolonged duration of action and a placebo-like tolerability. With the combination therapy, no significant change of pharmacokinetics of either component is observed. The fixed-dose combination results in a greater blood pressure reduction compared to monotherapy with either component. This is at least effective as or even more effective than the combination of atenolol or losartan with hydrochlorothiazide, respectively. The responder rate is about 90%. The safety and tolerability remain excellent. Beyond the antihypertensive effect, olmesartan significantly reduces vascular inflammation and the wall-to-lumen ration in arteries. The starting dose is 20/12.5 mg.

01 Jun 1990·American journal of hypertensionQ3 · MEDICINE

Effect of Dopamine on Renal Blood Flow, Prostaglandins, Renin and Electrolyte Excretion in Normal and Hypertensive Humans

Q3 · MEDICINE

Article

Author: E. Jost-Vu ; I. Antonipillai ; R. Horton ; S. Bughi ; J. Nadler

A low dose of dopamine (1 microgram/min/kg) infused for 3 h, which is without systemic hemodynamic effects in normal subjects, increased the renal blood flow and renal production of prostacyclin (PGI2). This action was blocked by metoclopramide as well as by either of two cyclooxygenase (CO) blockers, but effects were not altered by administration of the alpha 1 blocker prazosin. Much of the effect of dopamine (DA) is apparently via the DA1 receptor, since fenoldopam (0.1 microgram/min/kg) reproduced these actions. However, although fenoldopam increased glomerular filtration rate and urinary Na+, CO blockers were without effect. In contrast neither DA or fenoldopam infusions changed either renal blood flow or PGI2 in a group of patients with essential hypertension. Renin secretion was shown to be increased via DA1 receptor activation both in humans and rat renal tissue. The DA2 receptor may also play a role since domperidone can reduce renal blood flow.

100 Deals associated with Hydrochlorothiazide/Olmesartan Medoxomil

External Link

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R&D Status

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Indication	Country/Location	Organization	Date
Hypertension	US	Cosette Pharmaceuticals, Inc.Startup	05 Jun 2003
Essential Hypertension	DE	Daiichi Sankyo Europe GmbH	30 Mar 2003

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00430508 (CTgov)	Phase 3	Essential Hypertension	972	Placebo+HCTZ+OM (OM/HCTZ 40/25mg + 20/12.5 Matching Placebo)	nfhoyzkwnj(fqlkpchnpe) = utlbpvioit ukxemwftbf (uatrnlrixu, lqrfgrvwqp - acbvdnnglh) View more	-	17 Jun 2009
				Placebo+HCTZ+OM (OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo)	nfhoyzkwnj(fqlkpchnpe) = zlwqlvbprz ukxemwftbf (uatrnlrixu, mlmwpwpsit - vydbpcjnba) View more
NCT00890591 (Benibest, CTgov)	Phase 4	Essential Hypertension	144	Olmesartan (Olmesartan Monotherapy)	tpgbxohwvv(kwqdawillo) = cpaypbxneb kcfqxedmmx (fruvfvpjni, skwpcqrytp - xovnrpqblz)	-	30 Apr 2009
				Hydrochlorothiazide+Olmesartan (Olmesartan + Hydrochlorothiazide)	vfwyjdnhas(ruszlhepiz) = huijdeufmi mkscrxribj (xusvbfcovo, ulbengpjvg - aoakxefkhz) View more
NCT00430950 (CTgov)	Phase 3	Essential Hypertension	1,011	OM+HCTZ (OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo)	erqdfzwtwg(pjraqpwklt) = tisdnhjksj pdgazlbahx (ocymclygnt, yjaynsmqub - kvnimgvhxx) View more	-	20 Apr 2009
				OM+HCTZ (OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo)	erqdfzwtwg(pjraqpwklt) = ugvcujoykv pdgazlbahx (ocymclygnt, cmrnxrewhx - crkqsslske) View more

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