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

3,492

Literatures (Medical) associated with Perindopril Erbumine

01 Mar 2025·Journal of Hypertension

Differences in sex and age response to single pill combination based antihypertensive therapy reflecting in blood pressure and arterial stiffness

Article

Author: Vajer, Péter ; Jelaković, Bojan ; Brguljan Hitij, Jana ; Gaciong, Zbigniew ; Simić, Dragan ; Chazova, Irina E. ; Zelveian, Parounak

Objective:There are noticeable sex differences in the treatment response to antihypertensives, with limited data on the response to single pill combinations. The aim of the PRECIOUS trial was to assess the treatment response to perindopril/amlodipine and perindopril/amlodipine/indapamide dual and triple single-pill combination in men and women.Methods:Four hundred and forty adults with essential hypertension were assessed in the 16-week interventional, open-label, prospective, international, multicentre trial. Based on the previous antihypertensive therapy, patients were assigned to either perindopril/amlodipine 4/5 mg or perindopril/amlodipine/indapamide 4/5/1.25 mg, with the initial dose up-titrated in 4-week intervals in case of uncontrolled blood pressure. An additional analysis was performed for sex- and age-related differences on the blood pressure response and arterial stiffness in men and women aged 35–74 years.Results:Women achieved better overall blood pressure control in all age groups, except for the 35–44 age group. Women presented higher average 24 h aortic augmentation indexes than men, but had more pronounced decreasing trends. The pulse wave velocity was only age-dependent, with reductions slightly greater in women. Both the aortic augmentation index and pulse wave velocity were significantly decreased in all groups compared to baseline.Conclusions:The results of the PRECIOUS trial contribute significant data to the expanding body of evidence on sex differences in hypertension, including the aspect of age-related changes during the life course of women. The differences between same-aged men and women tend to be smaller with advancing age, but with a greater treatment response in women in all age groups for all observed blood pressure parameters and arterial stiffness.Trial registration:ClinicalTrials.gov identifier NCT03738761

17 Feb 2025·Future Cardiology

The role of single-pill ACE inhibitor/ccb combination for hypertension: an Algerian view via the nominal group technique

Review

Author: Haddoum, Farid ; Bouafia, Mohamed Tahar Chafik ; Bouraghda, Abed ; Manamani, Leila ; Chettibi, Mohamed ; Kichou, Brahim ; Laredj, Nadia ; Amara, Sofiane ; Lahmar, Hadj Mohamed Ali ; Kachenoura, Adjia ; Aoudia, Yazid ; Benchabi, Yasmina

Around one-third of adults in Algeria have hypertension, but > 40% are unaware they have the disease, and of those receiving treatment, only ~ 20-30% have adequate blood pressure (BP) control. Recommended starting treatment is an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker plus a calcium channel blocker (CCB) or diuretic. A single-pill combination of perindopril/amlodipine (ACEi/CCB) recently became available in Algeria. Twelve Algerian hypertension experts reviewed the clinical evidence regarding this therapeutic combination to determine its potential role for hypertension management in Algeria. The evidence indicated that this combination reduces cardiovascular outcomes and visit-to-visit BP variability, effectively controls 24-hour BP, and is well tolerated. In conclusion, the perindopril/amlodipine SPC provides a valuable new treatment option for hypertension in Algeria.

01 Feb 2025·Advances in Therapy

Simplified Approach to Managing Newly Diagnosed Patients with Mild-to-Moderate Hypertension in Routine Clinical Practice

Article

Author: Papacostas-Quintanilla, Helena ; on behalf of the Study Investigators ; Daskalopoulou, Stella S. ; Brzozowska-Villatte, Romualda

INTRODUCTIONThe aim of the observational SIMPLE study was to assess real-life effectiveness and safety of a single-pill combination (SPC) of perindopril arginine/amlodipine in a broad range of subjects with newly diagnosed mild-to-moderate hypertension treated in Canadian general practice.METHODSTreatment-naïve participants aged 18-65 years with mild-to-moderate hypertension, whose physicians decided to initiate the perindopril/amlodipine SPC, were recruited from Canadian clinical practice from October 2017 to February 2019. Participants were followed at 3- (M3) and 6-month (M6) visits after treatment initiation. The recommended starting dose of 3.5 mg/2.5 mg once daily was up-titrated, at the discretion of the treating physician, if blood pressure (BP) remained above target at subsequent visits. The primary endpoint was change in mean office systolic BP (SBP) and diastolic BP (DBP) at M6.RESULTSThe full analysis set included 1179 participants with a mean age of 51.5 ± 8.7 years; 61% were male. Mean SBP/DBP at baseline was 153.4 ± 11.5/94.8 ± 7.7 mmHg. Treatment was initiated at 3.5 mg/2.5 mg in 76.0% participants. Over the 6-month treatment period, significant (P < 0.001) decreases from baseline were observed for SBP (- 22.9 ± 14.5 mmHg) and DBP (- 13.4 ± 9.1 mmHg), with 70.2% of participants achieving their BP target. Across all perindopril/amlodipine SPC dose groups, 61.4% of participants achieved BP targets at M3; mean SBP was reduced by 20.8 ± 14.7 mmHg and DBP by 11.7 ± 9.2 mmHg (both P < 0.001). Analysis by baseline subgroup revealed significant BP reductions across age groups, sex, hypertension grades, and diabetes status. Participants with Grade 2 hypertension had a significantly greater decrease than those with Grade 1 (P < 0.001). Treatment with the SPC was well tolerated, and in the 6.1% with treatment-related adverse events, the majority were mild to moderate. High (99%) self-reported adherence (< 20 missed doses) in the 49.4% with available data and high physician satisfaction with treatment (82%) were reported.CONCLUSIONData from routine Canadian clinical practice indicate that a perindopril/amlodipine SPC is associated with significant BP reductions from baseline in a broad range of participants with different cardiovascular risk factors and may represent an appropriate first-line treatment for subjects with newly diagnosed hypertension.

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

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KEGG	Wiki	ATC	Drug Bank
D00624	Perindopril Erbumine	C09AA04	DB00790

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Diseases	Japan	Daiichi Sankyo Co., Ltd.	28 Sep 2005
Heart Failure	Netherlands	Servier Pharmaceuticals LLCStartup	-
Heart Failure	Greece	Servier Pharmaceuticals LLCStartup	-
Heart Failure	South Korea	Servier Pharmaceuticals LLCStartup	-
Hypertension	South Korea	Servier Pharmaceuticals LLCStartup	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 1	United States	Symplmed Pharmaceuticals LLC	30 Dec 1993
Hypertension	Phase 1	United States	Symplmed Pharmaceuticals LLC	30 Dec 1993

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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	gxzftdnwly(niuwqlljuz) = hsysdljare hmnzzdzuuv (uegqpgfcmd )	Positive	01 Apr 2024
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Canagliflozin 300 mg daily	(zscvxdrfsl) = jhdsmtzdwm ovimuhtsxr (jlioawbizq ) View more	Positive	01 Jun 2022
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Perindopril 10 mg daily	(zscvxdrfsl) = onlqvyicuh ovimuhtsxr (jlioawbizq ) View more	Positive	01 Jun 2022
ESH2021	Not Applicable	Obesity \| Hypertension	-	Perindopril 10 mg + Indapamide 2.5 mg	facztizgxr(jpqztkdbjh) = bqmahoehsx dgjwwefttf (ytcogsrpmj, 26 - 75;34 to 25) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	serum uric acid	40	Canagliflozin 100-300 mg	(wfqkobkzpn) = xwnakkngig acockhdeyd (knvoqwoxmw ) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	serum uric acid	40	Perindopril 10 mg	kviybocnyw(jvjzybfuuh) = vyrdnhwoex hfruprysor (popsdksmjv ) 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	(sypfczstsb) = dqibqvaoef epieacagxh (tmleokctqo ) View more	Positive	01 Jul 2019
NCT02651415 (Pubmed \| Cancer Chemother Pharmacol) Manual	Phase 2	Metastatic Colorectal Carcinoma	10	perindopril+regorafenib	ezsetrtxyf(ldqyyxqmbd) = vvdorzscva lkzefywazg (djckafoyin )	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)	weragosfnc(qkmekhtykr) = atgtywqsxu vaulkhpjtj (mcwaprtpzg, quzalimxrt - kyfxrewhqr) View more	-	11 Dec 2017
NCT01669434 (CTgov)	Phase 4	Hypotension	291	ACEI continuation (ACEI Continuation)	weragosfnc(qkmekhtykr) = eemndlzhgh vaulkhpjtj (mcwaprtpzg, wzsnmjsrwh - mlahpqgcvj) View more	-	11 Dec 2017
ASCOT-LLA (ESC2017)	Not Applicable	Hypertension	3,876	AmPA (atorvastatin + perindopril + amlodipine)	(gxamdxzkql) = 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) cjgqgbvzxh (nohefxybkx ) 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	kixnfdrflq(syliqivobf) = 4.5% of patients axdkjrljab (cblbhobgsx ) View more	-	26 Aug 2017

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