Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Start Date01 Jun 2015

Sponsor / Collaborator

University of Nebraska

CTR20132857 / Recruiting

群多普利胶囊用于高血压治疗的有效性及安全性的多中心、随机、双盲双模拟、阳性药对照临床试验

[Translation] A multicenter, randomized, double-blind, double-dummy, active-controlled clinical trial on the efficacy and safety of trandolapril capsules in the treatment of hypertension

评价群多普利胶囊用于高血压治疗的有效性与安全性

[Translation]

To evaluate the efficacy and safety of trandolapril capsules in the treatment of hypertension

Start Date06 Mar 2014

Sponsor / Collaborator

DDLD (Beijing) Pharmaceutical Technology Co., Ltd.

CTR20132838 / Completed

群多普利（ Trandolapril）胶囊健康人体空腹状态下三剂量（1 mg、2 mg及4 mg）单次及单剂量（ 2 mg）多次口服给药代动力学研究

[Translation] Study on the kinetics of Trandolapril capsules after single oral administration of three doses (1 mg, 2 mg and 4 mg) and single dose (2 mg) in healthy volunteers under fasting state

评估群多普利胶囊健康人体空腹状态下三剂量（1 mg、2 mg及4 mg）单次及单剂量（2 mg）多次口服给药药代动力学特征

[Translation]

To evaluate the pharmacokinetic characteristics of single oral administration of three doses (1 mg, 2 mg and 4 mg) and single dose (2 mg) of trandolapril capsules in healthy volunteers under fasting state

Start Date12 Jul 2013

Sponsor / Collaborator

DDLD (Beijing) Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Trandolapril

100 Translational Medicine associated with Trandolapril

100 Patents (Medical) associated with Trandolapril

659

Literatures (Medical) associated with Trandolapril

08 May 2024·NeuroReport

ADAMTS13 deficiency exacerbates neuroinflammation by targeting matrix metalloproteinase-9 in ischemic brain injury

Article

Author: Jiang, Hongxiang ; Chen, Qianxue ; Wu, Yu ; He, Peidong ; Hu, Juntao ; Li, Fei

Our design aimed to explore the potential involvement of matrix metalloproteinase-9 (MMP-9) in the inflammatory response associated with acute ischemic stroke (AIS). We also aimed to preliminarily examine the potential impact of a disintegrin-like and metalloprotease with thrombospondin type I repeats-13 (ADAMTS13) on MMP-9 in AIS. We conducted oxygen-glucose deprivation models of microglia cells and mice models of AIS with middle cerebral artery occlusion (MCAO). We assessed the expression pattern of MMP-9 with western blotting (WB) and real-time quantitative PCR both in vivo and in vitro. MMP-9 downregulation was achieved by using ACE inhibitors such as trandolapril. For the MCAO model, we used ADAMTS13-deficient mice. We then evaluated the related neurological function scores, cerebral edema and infarct volume. The levels of inflammation-related proteins, such as COX2 and iNOS, were assessed using WB, and the expression of inflammatory cytokines was measured via enzyme-linked immuno sorbent assay in vivo. Our findings indicated that MMP-9 was up-regulated while ADAMTS13 was down-regulated in the MCAO model. Knockdown of MMP-9 reduced both inflammation and ischemic brain injury. ADAMTS13 prevented brain damage, improved neurological function and decreased the inflammation response in mice AIS models. Additionally, ADAMTS13 alleviated MMP-9-induced neuroinflammation in vivo. It showed that ADAMTS13 deficiency exacerbated ischemic brain injury through an MMP-9-dependent inflammatory mechanism. Therefore, the ADAMTS13-MMP-9 axis could have therapeutic potential for the treatment of AIS.

01 May 2024·WMJ : official publication of the State Medical Society of Wisconsin

Use of Intravenous Lipid Emulsion Therapy and Insulin in a Case of Tarka Intoxication.

Article

Author: Arslan, İlknur ; Gün, Emrah ; Çiçek, Mahmut ; Kendirli, Tanıl ; Kafalı, Mustafa ; Demir, Hüsnü

INTRODUCTIONTarka (trandolapril/verapamil hydrohloride extended-release) is a fixed-dose combination antihypertensive drug formed from verapamil hydrochloride and trandolapril. Toxicologic manifestations of Tarka overdose are altered mental status, bradycardia, hypotension, atrioventricular block (first-degree), hyperglycemia, metabolic acidosis, and shock.CASE PRESENTATIONWe report a case of Tarka toxicity in a 2-year-old girl who presented with altered mental status, cardiogenic shock, hypotension, bradycardia, severe metabolic acidosis, hyperglycemia, and first-degree atrioventricular block. We started fluid resuscitation, epinephrine, norepinephrine, and insulin. Because of the patient's hyperlactatemia and hypotension despite standard therapies, we initiated intravenous lipid emulsion (ILE) therapy, after which her condition improved promptly.DISCUSSIONTarka overdose may be life-threatening as it can cause cardiogenic shock. In our patient, the regression of lactate elevation in a short time with ILE therapy and the improvement of her general condition highlight the importance of ILE.CONCLUSIONSILE is an alternative treatment method for acute lipophilic drug intoxications, such as Tarka.

06 Apr 2024·Biological and Pharmaceutical Bulletin

Angiotensin II Is Involved in MLKL Activation During the Development of Heart Failure Following Myocardial Infarction in Rats

Article

Author: Kurasawa, Minami ; Marunouchi, Tetsuro ; Tanonaka, Kouichi ; Onda, Sumika

Several reports assume that myocardial necroptotic cell death is induced during the development of chronic heart failure. Although it is well accepted that angiotensin II induces apoptotic cell death of cardiac myocytes, the involvement of angiotensin II in the induction of myocardial necroptosis during the development of heart failure is still unknown. Therefore, we examined the role of angiotensin II in myocardial necroptosis using rat failing hearts following myocardial infarction and cultured cardiomyocytes. We found that administration of azilsartan, an angiotensin II AT₁ receptor blocker, or trandolapril, an angiotensin-converting enzyme inhibitor, to rats from the 2nd to the 8th week after myocardial infarction resulted in preservation of cardiac function and attenuation of mixed lineage kinase domain-like (MLKL) activation. Furthermore, the ratio of necroptotic cell death was increased in neonatal rat ventricular cardiomyocytes cultured with conditioned medium from rat cardiac fibroblasts in the presence of angiotensin II. This increase in necroptotic cells was attenuated by pretreatment with azilsartan. Furthermore, activated MLKL was increased in cardiomyocytes cultured in conditioned medium. Pretreatment with azilsartan also prevented the conditioned medium-induced increase in activated MLKL. These results suggest that angiotensin II contributes to the induction of myocardial necroptosis during the development of heart failure.

News (Medical) associated with Trandolapril

01 Sep 2023

·www.fiercepharma.com

Fierce Pharma Asia—Vyvanse generics; Lenvima's trial flop; Adagene's ADC breakup

FDA approvals for Vyvanse generics, a Keytruda-Lenvima clinical trial flop and a dead deal between Adagene and ADC Therapeutics made our news this week. Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene. Plus more. 1. Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse The FDA has approved a slate of generics to Takeda’s ADHD drug Vyvanse. Teva, Sun Pharma, Actavis, Mylan and Hikma are among those that won the FDA’s blessing. The Takeda originator went into short supply a few weeks ago amid increased demand and a manufacturing hiccup. 2. Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial Merck and Eisai’s plan to combine Keytruda and Lenvima has suffered another setback. The companies decided to end a phase 3 trial in newly diagnosed PD-L1-positive head and neck cancer early. After reviewing interim data, they figured the combo likely won’t be able to outdo Keytruda alone at extending patients' lives. 3. ADC Therapeutics calls it quits on solid tumor collaboration with Adagene ADC Therapeutics has decided not to opt in on Chinese biotech Adagene’s antibody-drug conjugate program. The two teamed up in 2019 to combine Adagene’s antibody platform with ADC’s payload. ADC recently cut 17% of its workforce to save costs and to focus on FDA-approved Zynlonta and low-risk R&D projects. 4. Fujifilm Diosynth, planning for fast growth, reveals new structure and names unit leadership Fujifilm Diosynth Biotechnologies has reshaped its business structure. The company now has a large-scale strategic business unit headed by Kenneth Bilenberg in charge of the CDMO’s large facilities in Denmark and North Carolina supporting customers with large volume needs. Lee Kingsbury will oversee the company's small-scale production unit. 5. Glenmark, Baxter issue separate recalls for hypertension and cancer drugs Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets produced at a site in India. The drugs are used to treat high blood pressure but were found to be subpotent in a three-month test. 6. Genexine's weekly growth hormone equal to Novo shot in phase 3, teeing up filing in China South Korean biotech Genexine said its once-weekly growth hormone, eftansomatropin alfa, matched Novo Nordisk’s daily Norditropin in a phase 3 trial in Chinese children with growth hormone deficiency. I-Mab, through its acquisition of Tasgen Biotech, owns rights to eftansomatropin alfa in China. 7. CanSino paused mRNA COVID vaccine development, looks for more CDMO deals (Reuters) China’s CanSino Biologics has paused development of mRNA COVID vaccines, co-founder and CEO Xuefeng Yu told Reuters. For its newly built mRNA facility in Shanghai, CanSino is now looking to manufacture vaccines for other companies, just as in its recent deal with AstraZeneca.

Phase 3VaccineClinical ResultDrug ApprovalmRNA

28 Aug 2023

·www.fiercepharma.com

Glenmark, Baxter issue separate recalls for hypertension and cancer drugs

Glenmark USA and Baxter Healthcare issue separate voluntary recalls for blood pressure tables and an injectable cancer drug, respectively. Glenmark Pharmaceuticals USA and Baxter Healthcare issued separate recalls citing out-of-specification tests and problems with labels for drugs used to treat hypertension and cancer, respectively. Both recalls are designated as Class III, meaning the products in question violate federal regulations but are unlikely to cause adverse health consequences. Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure. In a notice, the company said an assay test at the three-month time point found the drug to be subpotent. The company produced the medicine at one of its sites in India. The tablets had been distributed nationwide in the U.S. Baxter, meanwhile, recently issued a voluntary recall for 13,502 vials of bendamustine HCl injection, which is used to treat cancers such as lymphoma and chronic lymphocytic leukemia. The drug is being recalled after a customer complaint flagged issues with labels falling off the vials. India-based Glenmark is no stranger to FDA scrutiny and recalls. Late last year, an FDA warning letter flagged issues with batch failures, lab controls, record-keeping and more at a site in Colvale, India. A separate assay test by the company had prompted a prior recall in June 2022. As for Baxter, the company recently sold its biopharma solutions unit to private equity firms Warburg Pincus and Advent International in a $4.25 billion deal. That standalone company just named a new CEO in Franco Negron.

100 Deals associated with Trandolapril

External Link

KEGG	Wiki	ATC	Drug Bank
D00383	Trandolapril	C09AA10	DB00519

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	JP	Nippon Shinyaku Co., Ltd.	31 Jan 1996

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01669434 (CTgov)	Phase 4	Hypotension	291	LISINOPRIL+Captopril+ENALAPRILAT+BENAZEPRIL HYDROCHLORIDE+PERINDOPRIL ERBUMINE+RAMIPRIL+QUINAPRIL HYDROCHLORIDE+Enalapril Maleate+Perindopril Arginine+FOSINOPRIL SODIUM+TRANDOLAPRIL+MOEXIPRIL HYDROCHLORIDE (ACEI Omission)	gioijuvrpt(dslvozmjfi) = fzblvktfjp oumiptvvbo (uiiczfbwee, tjcgmzfkxy - dahqdwgjxs) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	gioijuvrpt(dslvozmjfi) = jdsvtumnwu oumiptvvbo (uiiczfbwee, twannurqoe - eicnztcjhx) View more
NCT00887510 (MEAD, CTgov)	Phase 4	Metabolic Syndrome \| Hypertension	24	Hydrochlorothiazide+Trandolapril (Thiazide First)	uvgidpeuzn(skhxkchnpo) = uqbzbalybm nizlulwgwy (iggjouxnto, xxaneksmkg - fzkmdtbdax) View more	-	17 Jun 2014
				Hydrochlorothiazide+Trandolapril (Trandolapril First)	uvgidpeuzn(skhxkchnpo) = ojncypthuf nizlulwgwy (iggjouxnto, ppjhnohiye - telpgyiphj) View more
NCT00235014 (BENEDICT-B, Pubmed \| J Hypertens)	Phase 4	Diabetic Nephropathies \| Hypertension	281	Verapamil/trandolapril 180 mg/2 mg daily	yazvrgtfom(edqrbizypc): hazard ratio = 0.93 (95% CI, 0.5 - 1.72), P-Value = 0.816 View more	Negative	01 Feb 2011
				Trandolapril 2 mg daily
NCT00840632 (CTgov)	Phase 1	-	40	Trandolapril 4 mg Tablets (Trandolapril)	nlxljamgup(ohfxkqvenv) = dhtoqznbiu iwhqaatrzc (yjeafwrsyu, nrpfzldfve - oxdtyoqcyl) View more	-	18 Aug 2009
				Mavik® 4 mg Tablets (Mavik®)	nlxljamgup(ohfxkqvenv) = hwbkjrvsye iwhqaatrzc (yjeafwrsyu, ofeliebjwq - vvoloywkbv) View more
NCT00840073 (CTgov)	Phase 1	-	50	Trandolapril 4 mg Tablets (Trandolapril)	cwtfiosxpb(rzxfviapfa) = upkhzufyfs flfrawkpml (fiyscmmyys, zlnerprzuu - tmkjxwwpdf) View more	-	18 Aug 2009
				Mavik® 4 mg Tablets (Mavik®)	cwtfiosxpb(rzxfviapfa) = vmwatqnlwm flfrawkpml (fiyscmmyys, beaatxrgzg - axisvmvigf) View more

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