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

647

Literatures (Medical) associated with Trandolapril

01 Feb 2024·Pharmacology research & perspectives

The impact of phosphodiesterase‐5 inhibition or angiotensin‐converting enzyme inhibition on right and left ventricular remodeling in heart failure due to chronic volume overload

Article

Author: Kotrc, Martin ; Novotny, Jiri ; Skop, Vojtech ; Skaroupkova, Petra ; Trnovska, Jaroslava ; Miklovic, Matus ; Kazdova, Ludmila ; Melenovsky, Vojtech ; Tykvartova, Tereza ; Kolar, Michal

Abstract:

While phosphodiesterase‐5 inhibition (PED5i) may prevent hypertrophy and failure in pressure‐overloaded heart in an experimental model, the impact of PDE5i on volume‐overload (VO)‐induced hypertrophy is unknown. It is also unclear whether the hypertrophied right ventricle (RV) and left ventricle (LV) differ in their responsiveness to long‐term PDE5i and if this therapy affects renal function. The goal of this study was to elucidate the effect of PDE5i treatment in VO due to aorto‐caval fistula (ACF) and to compare PDE5i treatment with standard heart failure (HF) therapy with angiotensin‐converting enzyme inhibitor (ACEi). ACF/sham procedure was performed on male HanSD rats aged 8 weeks. ACF animals were randomized for PDE5i sildenafil, ACEi trandolapril, or placebo treatments. After 20 weeks, RV and LV function (echocardiography, pressure‐volume analysis), myocardial gene expression, and renal function were studied. Separate rat cohorts served for survival analysis. ACF led to biventricular eccentric hypertrophy (LV: +68%, RV: +145%), increased stroke work (LV: 3.6‐fold, RV: 6.7‐fold), and reduced load‐independent systolic function (PRSW, LV: −54%, RV: −51%). Both ACF ventricles exhibited upregulation of the genes of myocardial stress and glucose metabolism. ACEi but not PDE5i attenuated pulmonary congestion, LV remodeling, albuminuria, and improved survival (median survival in ACF/ACEi was 41 weeks vs. 35 weeks in ACF/placebo, p = .02). PDE5i increased cyclic guanosine monophosphate levels in the lungs, but not in the RV, LV, or kidney. PDE5i did not improve survival rate and cardiac and renal function in ACF rats, in contrast to ACEi. VO‐induced HF is not responsive to PDE5i therapy.

02 Jan 2024·Expert review of clinical pharmacology

The association between ACE inhibitors and psoriasis based on the drug-targeted Mendelian randomization and real-world pharmacovigilance analyses

Article

Author: Jin, Qiubai ; Ren, Feihong ; Song, Ping

BACKGROUND:

Although a growing number of observational studies suggest that angiotensin-converting enzyme inhibitors (ACEIs) intake may be a risk factor for psoriasis, evidence is still insufficient to draw definitive conclusions.

RESEARCH DESIGN AND METHODS:

Drug-targeted Mendelian randomization (DTMR) was used to analyze the causality between genetic proxied ACEIs and psoriasis. Furthermore, we performed a disproportionality analysis based on the FDA adverse event reporting system (FAERS) database to identify more suspicious subclasses of ACEIs.

RESULTS:

Using two kinds of genetic proxy instruments, the present DTMR research identified genetic proxied ACEIs as risk factors for psoriasis. Furthermore, our disproportionality analysis revealed that ramipril, trandolapril, perindopril, lisinopril, and enalapril were associated with the risk of psoriasis, which validates and refines the findings of the DTMR.

CONCLUSIONS:

Our integrative study verified that ACEIs, especially ramipril, trandolapril, perindopril, lisinopril, and enalapril, tended to increase the risk of psoriasis statistically.

01 Nov 2023·Georgian medical news

MELANOMA AND DYSPLASTIC NEVI DEVELOPMENT AFTER RANITIDINE/RILMENIDINE/МOXONIDINE, LERCANIDIPINE, ROSUVASTATIN AND VERAPAMIL/TRANDOLAPRIL - NEW DATA/CASE SERIES. THE POTENTIAL ROLE OF NITROSAMINE/NDSRIS CONTAMINATION IN POLYMEDICATION AS SUBSTANTIAL SKIN CANCER TRIGGERING FACTOR.

Article

Author: Naydekova, N ; Tchernev, G

The idea of drug-induced/exogenic Nitrosogenesis is driven by the possibility of prolonged exposure of the human body to the influence of nitrosamines within the drug intake - substances or contaminants that have been proven to be carcinogenic or mutagenic one.Until recently, there was a complete lack of data in the scientific literature on the relationship between cancer, polymedication and polycontamination with nitrosamines. In the last decade, melanoma has been described repeatedly in the medical literature as a possible side-effect within the intake of possibly with nitrosamines contaminated medications such as: Valsartan, Hydrochlorothiazide, Amlodipine, Nebivolol, Bisoprolol and Perindopril. However, the contribution of the currently presented new data (5 new patients) is also due to the establishment of the possible pathogenetic role (with respect to melanoma) of several completely new drugs, previously unknown to the scientific community (potentially/actually contaminated with carcinogens/nitrosamines), such as: Ranitidine, Rosuvastatin, Lercanidipine, Rilmenidine, Trandolapril, Moxonidine and Verapamil.The leading and connecting link in shared new and old drug combinations of heterogeneous drug classes (polymedication) and melanoma development and progression remains again one and the same: the possible availability of nitroso component in the frame of exogenous nitrosogenesis according to the official FDA lists of 2023.The number of drugs shared as contaminated with nitrosamines after whose intake melanomas occur is increasing. Nitrosogenesis remains a new beginning, a new understanding and new interpretation of the carcinogenesis concerning melanoma, but probably also of cancer in general. Its further elucidation looks more than promising and is yet to come. More than worrying at the moment remains the fact that the scientific community has to clarify if: 1) peak concentrations of nitrosamines or NDSRIs within the framework of monomedication or 2) normal concentrations within the polymedication (catalogued in the list of FDA/ 2023 as potentially contaminated with hypothetical carcinogens), could hide relatively short-term risk of the development of real tumors: cutaneous melanomas and/or their precursor lesions. The validation of the concept of Nitrosogenesis and its relationship to Сarcinogenesis, is achieved in practice on the basis of the following facts: that it is the occurrence of the same monomorphic clinical pattern (melanoma/dysplastic nevi), developing after the intake of drugs with different mechanism of action, contaminated with nitrosamines/NDSRIs. The unifying link between the intake of certain drugs and the development of certain tumours remains the presence of nitrosamines. Ingredients that are present in drug preparations, identified as availability and as carcinogenic potency, but not yet reflected in packaging or prescriptions. The question remains: why?

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)	dtxgukgjna(hlvahknysh) = jmgixysfmj panfpykrhx (gnmfmhmkse, ooohcfgahl - hgprpejtcj) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	dtxgukgjna(hlvahknysh) = jccdysmmdh panfpykrhx (gnmfmhmkse, hsliawopda - dxssleuoet) View more
NCT00887510 (MEAD, CTgov)	Phase 4	Metabolic Syndrome \| Hypertension	24	Hydrochlorothiazide+Trandolapril (Thiazide First)	uvctuqrliq(bltbthxxex) = odnsetxpwf dnuwepzbnh (ifwdqsmned, edbtwtqxjo - fbfetvlxyx) View more	-	17 Jun 2014
				Hydrochlorothiazide+Trandolapril (Trandolapril First)	uvctuqrliq(bltbthxxex) = qulhasorjt dnuwepzbnh (ifwdqsmned, ruwunqyxvw - rjuwijcgcv) View more
NCT00391846 (CTgov)	Phase 4	Heart Failure \| Left ventricular systolic dysfunction	252	The Kansas City Cardiomyopathy Questionnaire (KCCQ)+Valsartan+Eplerenone+Ramipril+Trandolapril+Lisinopril+Captopril+Metoprolol succinate+Candesartan+Spironolactone+Enalapril+Carvedilol+Bisoprolol (Guided by NT-proBNP)	ypxwflafph(jkvkzxigtb) = avvnmegizw wgncyroqrg (emhkwnkjcd, sjbakrfbig - rmdmqgjuex) View more	-	18 Jun 2012
				The Kansas City Cardiomyopathy Questionnaire (KCCQ)+Valsartan+Eplerenone+Ramipril+Trandolapril+Lisinopril+Captopril+Metoprolol succinate+Candesartan+Spironolactone+Enalapril+Carvedilol+Bisoprolol (Not Guided by NT-proBNP)	ypxwflafph(jkvkzxigtb) = usjmjbsrhz wgncyroqrg (emhkwnkjcd, hhbewxylym - qossfqiybl) View more
NCT00235014 (BENEDICT-B, Pubmed \| J Hypertens)	Phase 4	Diabetic Nephropathies \| Hypertension	281	Verapamil/trandolapril 180 mg/2 mg daily	tarbmpexho(mcexizzeik): hazard ratio = 0.93 (95% CI, 0.5 - 1.72), P-Value = 0.816 View more	Negative	01 Feb 2011
				Trandolapril 2 mg daily
NCT00840073 (CTgov)	Phase 1	-	50	Trandolapril 4 mg Tablets (Trandolapril)	glbsdaazul(qbjveanzsu) = gvnpvfrcbt hafuiuuaxe (oyryotvifs, exdpwekuuh - mxvxcguxee) View more	-	18 Aug 2009
				Mavik® 4 mg Tablets (Mavik®)	glbsdaazul(qbjveanzsu) = whsddwkrae hafuiuuaxe (oyryotvifs, exntywcquu - qdyducxrqp) View more
NCT00840632 (CTgov)	Phase 1	-	40	Trandolapril 4 mg Tablets (Trandolapril)	waszwnmjqj(ezdxmthuuv) = gletlbwdps yhhnwlgspz (frxfnlypxd, rebtyytqjy - uabquwudof) View more	-	18 Aug 2009
				Mavik® 4 mg Tablets (Mavik®)	waszwnmjqj(ezdxmthuuv) = jmuqzftwtt yhhnwlgspz (frxfnlypxd, esghgiijuu - dzjagfpjet) View more

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