FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy in adults and children 5 years or older.

Start Date01 Jun 2024

Sponsor / Collaborator-

NCT06341101

/ RecruitingPhase 4IIT

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:
Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.
Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure.

Start Date26 Mar 2024

Sponsor / Collaborator

Academisch Ziekenhuis Maastricht

[+1]

NCT06213610

/ RecruitingPhase 1

Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril (Perindopril Tert-butylamine) 8 mg (Pharmtechnology LLC, Republic of Belarus) and Prestarium® A 10 mg (Perindopril Arginine) 10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Prestarium ® A 10 mg tablets) or the test (Perindopril 8 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Start Date09 Jan 2024

Sponsor / Collaborator

Pharmtechnology, LLC

100 Clinical Results associated with Perindopril Erbumine

100 Translational Medicine associated with Perindopril Erbumine

100 Patents (Medical) associated with Perindopril Erbumine

2,224

Literatures (Medical) associated with Perindopril Erbumine

01 Jan 2025·Brain Research

Involvement of Renin-Angiotensin system (RAS) components in mild traumatic brain injury

Article

Author: de Barros, João Luís Vieira Monteiro ; Silva de Miranda, Aline ; de Miranda, Aline Silva ; Luís Vieira Monteiro de Barros, João ; Fernandes, Heliana de Barros ; Simões E Silva, Ana Cristina ; Oliveira, Bruna da Silva ; Miranda Kangussu, Lucas ; Lúcio Teixeira, Antônio ; Machado, Caroline Amaral ; Cristina Simões e Silva, Ana ; Cristina de Brito Toscano, Eliana ; Amaral Machado, Caroline ; Guimarães, Pedro Pires Goulart ; da Silva Oliveira, Bruna ; de Barros Fernandes, Heliana ; Pires Goulart Guimarães, Pedro ; de Brito Toscano, Eliana Cristina ; Kangussu, Lucas Miranda ; Teixeira, Antonio Lucio

The Renin Angiotensin System (RAS) plays a pathophysiological role in traumatic brain injury (TBI) but the evidence of its involvement in mild TBI (mTBI) is still limited. We aimed at investigating the levels of components from both the classical and counter-regulatory axis of the RAS in a mTBI animal model. Mice with mTBI displayed enhanced ACE/Ang II/AT₁R axis ipsilateral- and contralaterally to the trauma in the hippocampus and prefrontal cortex during acute (24 and 72 h) and later (30 days) timepoints. Increase in Ang-(1-7) levels alongside reduction in Mas receptor expression in hippocampus and prefrontal cortex was also observed after injury. Conversely, mTBI-mice presented higher expression of AT₂ receptor in the contralateral hippocampus and the ipsilateral prefrontal cortex. Importantly, treatment with telmisartan, an AT₁R blocker, and perindopril, an ACE inhibitor, were able to prevent mTBI-associated locomotor activity impairment and anxiety-like behavior, corroborating the involvement of RAS in the pathophysiology of mTBI. We provided original evidence that components of classical and alternative RAS axes undergo alterations in key brain areas following a mTBI in a time and hemisphere dependent manner. Our findings also open new avenues for investigating the therapeutic potential of RAS components in mTBI.

01 Jan 2025·Journal of Chromatography A

Enhancing the practicality along with greenness sustainability of a high throughput HPLC-MS/MS bioanalytical method for the simultaneous determination of amlodipine, perindopril, and its active metabolite perindoprilat in human plasma: Application to a pharmacokinetic study

Article

Author: Elkady, Ehab F ; Sayed, Rawda M ; Moffid, Marwa A ; Mostafa, Eman A

Numerous studies have demonstrated the benefits of amlodipine and perindopril combination therapy in decreasing blood pressure and improving outcomes for high-risk patients. In order to assess the pharmacokinetics of the 2 drugs along with perindoprilat; the active metabolite of perindopril, a simultaneous LC-MS/MS quantification method of amlodipine (AML), perindopril (PER) and perindoprilat (LAT) in human plasma has been developed and validated using amlodipine D4, perindopril D4 and perindoprilat D4 as internal standards (ISs), respectively. A simple and fast protein precipitation method was used to analyze the three analytes from K₃EDTA human plasma. The chromatographic separation included the use of a mixture of methanol and acetonitrile (80:20, v/v) and 0.2 % aqueous formic acid (60:40, v/v) as a mobile phase pumped onto a Zorbax® SB-AQ C18 column. Detection was carried out using a tandem mass spectrometer (MS/MS) in multiple reactions monitoring (MRM) mode. This method exhibited great sensitivity (LLOQ of 0.2 ng/mL for AML and PER and 0.4 ng/mL for LAT), linearity, accuracy (ranging from 97.64 % to 110.28 %), precision (ranging from 2.54 % to 7.60 %), and stability. The method showed good linearity over the range of (0.2-10 ng/mL) for AML, (0.2-160 ng/mL) for PER and (0.4-80 ng/mL) for LAT. The average extraction recoveries of AML, PER and LAT samples were between 81.92 % and 85.07 %. Total elution time was as low as 3 min only. In addition, to ensure the practicality of the developed method, BAGI tool was applied, and the current method has achieved the highest score among the compared methods. Moreover, the sustainability of the proposed method was evaluated using AGREE tool and RGB 12 paradigm showing remarkable sustainability. The developed method is fast, accurate, sensitive, reproducible, ecofriendly, sustainable and suitable for the determination of the concentration of the cited analytes in human plasma. Moreover, it was applied for the bioequivalence study of a generic product to the innovator.

01 Dec 2024·International Journal of Cardiology Cardiovascular Risk and Prevention

Treatment optimisation for blood pressure with single-pill combinations in India (TOPSPIN) – Protocol design and baseline characteristics

Article

Author: Abichandani, Vinod K. ; Kiru, Gaia ; Patil, Satish G ; Gupta, Bal Kishan ; Shailendra, D. ; Cornelius, Victoria R ; Salwa, Hyndavi ; Patil, Satish G. ; Sengupta, Shantanu ; Aithal, Kiran ; Mahajan, Gayatri ; Roy, Ambuj ; Singh, Bhupinder ; Abichandani, Vinod K ; Mishra, Animesh ; Bardoloi, Neil ; Malviya, Amit ; Lobo, Ameeka Shereen ; Chandrasekaran, Ambalam M. ; Gupta, B.K. ; Mukherjee, Somnath ; Poulter, Neil ; Khanna, Mallika ; Cornelius, Victoria R. ; Kumar, Sunil ; Singh, Kavita ; Yellapantula, Balsubramaiam ; Mohan, Bishav ; Kondal, Dimple ; Christa, Edmin ; Chandrasekaran, Ambalam M ; Chavda, Vipul ; Shailendra, Dandge ; Prabhakaran, Dorairaj ; Khanna, Aman

BackgroundThe burden of over 300 million individuals living with hypertension in India is increasing steadily. Most current guidelines recommend initial combination therapy for effective blood pressure (BP) control. However, there is no randomised evidence to inform which combinations to use in the South Asian population, who account for over one-quarter of the world's population.MethodsThis multi-centre, single-blind, randomised, three-arm trial recruited men and women aged 30-79 years with hypertension. The trial compares the efficacy of commonly recommended single pill combinations (SPCs) of three drug classes - calcium channel blocker (amlodipine), ACE inhibitor (perindopril), and a thiazide-like diuretic (indapamide). The primary objective is to determine the most effective two-drug combination, initially at starting doses with forced up-titration at 2 months, in reducing 24-h ambulatory systolic blood pressure (ASBP) at 6 months. The trial has 85 % power to detect a difference of 3 mmHg in 24-h ASBP amongst the groups.Participant recruitment took place from August 2022 to February 2024.Baseline resultsThe 1981 participants (42.0 % women) enrolled had a mean age of 52.1 (SD 11.3) years and a mean body mass index of 26.5 (SD 4.2) kg/m2. 58.1 % of participants had a previous diagnosis of hypertension and 18.6 % of participants were known to diabetes. The mean ASBP was 135.6 (SD 17.0) mmHg, and the mean ambulatory diastolic BP was 84.5 (SD 10.9) mmHg.ConclusionThe TOPSPIN trial is the first randomised evaluation of commonly used BP-lowering combination therapies in a South Asian population. The results have potentially significant implications for choosing first-line antihypertensive agents among Indians and the South Asian diaspora.

News (Medical) associated with Perindopril Erbumine

11 Sep 2024

·www.drugs.com

Quadruple Single Pill Superior for Resistant Hypertension

WEDNESDAY, Sept. 11, 2024 -- For patients with resistant hypertension , a quadruple single pill is superior to triple therapy, according to a study presented at the European Society of Cardiology Congress, held from Aug. 30 to Sept. 2 in London. Stefano Taddei, from the University of Pisa in Italy, and colleagues conducted a double-blind, randomized trial involving patients with resistant hypertension. Participants completed an eight-week run-in period during which they received the triple combination of perindopril, indapamide, and amlodipine. Those with uncontrolled blood pressure (BP) after eight weeks while adherent to therapy were randomly allocated to continue the same triple therapy or receive a single-pill combination containing perindopril, indapamide, amlodipine, and bisoprolol. A total of 183 patients from 49 centers in 13 countries were included in the trial. The researchers found that the mean office sitting systolic BP was reduced by 20.67 and 11.32 mm Hg in the quadruple single-pill group and in the triple group, respectively, after eight weeks, with the adjusted difference significant in favor of the quadruple single pill. For the main secondary end point of mean 24-hour ambulatory systolic BP, there was a significant difference for the quadruple single pill versus the triple group (−7.53 mm Hg); in addition, there was a significant difference in favor of the quadruple single-pill group in mean office sitting diastolic BP (−6.14 mm Hg). BP control was achieved by 66.3 and 42.7 percent on the quadruple single pill and on triple therapy, respectively. "The availability of a quadruple single-pill combination that includes bisoprolol could help with non-adherence and provide much-needed effective BP control in patients with resistant or difficult-to-treat hypertension," Taddei said in a statement. Several authors disclosed ties to the pharmaceutical and medical device industry, including Servier, which funded the study. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

21 Feb 2024

·www.biospace.com

Discover this new generic drug in the PERINDOPRIL range

MONTREAL, Feb. 21, 2024 /CNW/ - Pharmascience Canada is proud to announce the launch of pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine), a drug indicated for the treatment of mild to moderate essential hypertension in adults aged 18 to 65 for whom combination therapy is appropriate. This oral treatment contains two medicines, perindopril arginine and amlodipine. They work together to control the blood pressure. pms-PERINDOPRIL-AMLODIPINE are available in bottles of 100 tablets and comes in the following dosage forms: 3.5 mg / 2.5 mg (this treatment is indicated for initial therapy in patients with mild to moderate essential hypertension.) 7 mg / 5 mg 14 mg / 10 mg This medication is a generic equivalent of Viacoram MD1. pms-PERINDOPRIL-AMLODIPINE tablets are available at affordable prices. « We are excited to introduce Perindopril Amlodipine to the Canadian market, as it reflects our mission to improve the health and quality of life of Canadians through innovative and high-quality products, » said Mike Dutton, Vice-President and General Manager of Pharmascience Canada. « Perindopril Amlodipine is manufactured in our Canadian facility which is another example of how we leverage our expertise and capabilities to deliver value to our customers and patients. » ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2024, the company was awarded Great Place to Work certification for the third year running. PRVIACORAM®1 is a registered trademark owned by Servier Canada Inc. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. SOURCE Pharmascience Inc.

Drug Approval

05 Sep 2023

·www.biospace.com

Pharmascience Canada launches a new generic drug to treat hypertension

[05-September-2023] MONTREAL, Sept. 5, 2023 /CNW/ - pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine / indapamide) is used in adults for the initial treatment of mild to moderate essential hypertension (high blood pressure). pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine/ indapamide) are a combination of perindopril erbumine, an angiotensin converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl diuretic. These two active ingredients act synergistically to lower blood pressure in hypertensive patients of all ages. pms-PERINDOPRIL-INDAPAMIDE comes in the following dosage forms: Tablets of 2 mg perindopril erbumine/ 0.625 mg indapamide. Tablets of 4 mg perindopril erbumine/ 1.25 mg indapamide. Tablets of 8 mg perindopril erbumine/ 2.5 mg indapamide. pms-PERINDOPRIL-INDAPAMIDE is a generic equivalent to Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD and has the same safety and efficacy as Coversyl®. pms-PERINDOPRIL-INDAPAMIDE tablets are offered at a lower price than brand-name products. "The Pharmascience team is happy to bring to market pms-Perindopril-Indapamide used for the initial treatment of high blood pressure. The availability of pms-Perindopril-Indapamide gives every Canadian an affordable and important treatment option! At Pharmascience, we take tremendous pride in our locally produced medicines and will continue to focus on growing our portfolio with quality medications needed for all Canadians!" - mentioned Mike Dutton, Vice President, and General Manager of Pharmascience Canada. ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2023, Pharmascience Inc. has proudly been recognized for its investments by being selected as one of Canada's Top Employers for Young People as part of Canada's Top 100 Employers. Pharmascience is now certified as a Great Place to Work for a second year in a row. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD are registered trademark owned by Servier Canada Inc. SOURCE Pharmascience Inc.

Drug Approval

100 Deals associated with Perindopril Erbumine

External Link

KEGG	Wiki	ATC	Drug Bank
D00624	Perindopril Erbumine	C09AA04	DB00790

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Diseases	JP	Daiichi Sankyo Co., Ltd.	28 Sep 2005
Heart Failure	KR	Servier Pharmaceuticals LLCStartup	-
Heart Failure	NL	Servier Pharmaceuticals LLCStartup	-
Heart Failure	GR	Servier Pharmaceuticals LLCStartup	-
Hypertension	KR	Servier Pharmaceuticals LLCStartup	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISN WCN2024	Not Applicable	Diabetes Mellitus \| Kidney Failure, Chronic	155	Perindopril	idpcoxbtej(ildmcouxkk) = zbtbhltyyi ldzfugbhwj (efbxclpyte )	Positive	01 Apr 2024
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Canagliflozin 300 mg daily	(uxsgldwrry) = vackjexnpi glbmpvynrf (venpprupgi ) View more	Positive	01 Jun 2022
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Perindopril 10 mg daily	(uxsgldwrry) = fzyigcmwyi glbmpvynrf (venpprupgi ) View more	Positive	01 Jun 2022
ESH2021	Not Applicable	serum uric acid	40	Canagliflozin 100-300 mg	(eccumpcaaf) = hmjgrbwivw ejkwunnkie (akixeokldp ) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	serum uric acid	40	Perindopril 10 mg	wljpconyik(yhytdsybwe) = fmbjgghxcc ahynfnuwal (wwtnlkrktg ) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	Obesity \| Hypertension	-	Perindopril 10 mg + Indapamide 2.5 mg	qazqvfgzlw(etoscwciqw) = sgbkxhpoyu wgjiwpiqym (mwpfvlhfqf, 26 - 75;34 to 25) View more	Positive	01 Apr 2021
ESH2019	Not Applicable	Diabetes Mellitus, Type 2 metalloproteinase-9 (MMP-9) \| tissue inhibitor of metalloproteinase 1 (TIMP-1) \| E-selectin ... View more	30	Perindopril 10 mg/day	(ikmrqlorzx) = woqagogajc xwbnmxvbyf (zlngzwapbb ) View more	Positive	01 Jul 2019
NCT02651415 (Pubmed \| Cancer Chemother Pharmacol) Manual	Phase 2	Metastatic Colorectal Carcinoma	10	perindopril+regorafenib	clwwogtxcy(wduzirlfmv) = rlicqhphrx qowunoqkly (jarsuuikxy )	Negative	01 Mar 2019
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)	oqslfmmyuj(yodkpamrnt) = wkccnamuio piwsrzqcjc (plfcorgehs, cccpgcbfdi - ktnlegcjbj) View more	-	11 Dec 2017
NCT01669434 (CTgov)	Phase 4	Hypotension	291	ACEI continuation (ACEI Continuation)	oqslfmmyuj(yodkpamrnt) = lcefzcxwpa piwsrzqcjc (plfcorgehs, qxpdgzkxnd - irpanmhrlt) View more	-	11 Dec 2017
ASCOT-LLA (ESC2017)	Not Applicable	Hypertension	3,876	AmPA (atorvastatin + perindopril + amlodipine)	(wcupfyvtun) = Fewer patients experienced at least one serious non non-fatal adverse event in the AmPA group than in the AmPP group (9.5% vs 10.3% respectively, p=0.006) jbnqiafsog (gwguvfqqmw ) View more	Positive	29 Aug 2017
ASCOT-LLA (ESC2017)	Not Applicable	Hypertension	3,876	AmPP (placebo + perindopril + amlodipine)		Positive	29 Aug 2017
ESC2017	Not Applicable	Hypertension	-	Perindopril+Atorvastatin	riqkpumeqx(ikytzailny) = 4.5% of patients gyuhkxivoh (polbqlwbdf ) View more	-	26 Aug 2017

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