Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

The purpose of this study is:
To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression.
To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Start Date01 Nov 2012

Sponsor / Collaborator

OOO NPF Materia Medica Holding

100 Clinical Results associated with Afalaza

100 Translational Medicine associated with Afalaza

100 Patents (Medical) associated with Afalaza

Literatures (Medical) associated with Afalaza

04 Mar 2022·Urologiia

Management of lower urinary tract symptoms in patients with benign prostatic hyperplasia during COVID-19. results of an all-russian observational study “ATLANT”

Article

Author: Neymark, A I ; Nozdrachev, N A ; Ibishev, Kh S ; Kuzmin, I V ; Neymark, B A ; Yakovets, Ya V

BACKGROUNDCOVID-19 aggravates lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH). The optimal treatment regimen for patients with this disease during the COVID-19 pandemic is still under question.OBJECTIVESThe aim of the All-Russian observational study of Afalaza in the Treatment of LUTS in pAtieNTs with BPH during COVID-19 (ATLANT) was to obtain additional data on the efficacy and safety of Afalaza in this patient group.METHODs. The study enrolled 73 men aged 46-65 years with LUTS and diagnosed BPH who suffered from COVID-19. All patients received Afalaza for 16 weeks. The dynamics of BHP indicators, erectile function, and quality of life were assessed after 4, 12, and 16 weeks of treatment.RESULTSPatients with LUTS/BHP who suffered from COVID-19 had a decrease in the total IPSS score from 21.6+/-8.6 to 6.4+/-2.4 (-70.4%) points after 16 weeks of treatment. There was a direct correlation between COVID-19 duration (and beginning of therapy) and the severity of symptoms after Afalaza treatment. According to the subjective assessment of patients, there was a significant increase in the quality of life and erectile function after 16 weeks of treatment. 9 mild AEs were registered in 12.3% of patients and were unrelated to the study drug.CONCLUSIONSResults show that Afalaza may be a perspective drug for the treatment of LUTS/BPH in patients with COVID-19 and be used for this urological disease in the current COVID-19 pandemic.

18 Jul 2019·Urologiia

The experience of using drug Afalaza for treatment of lower urinary symptoms in treatment-naïve patients with benign prostatic hyperplasia

Article

Author: Soloviev, V V ; Rokhlikov, I M ; Epstein, O I ; Kupriyanov, Yu A ; Nozdrin, E V ; Markov, A A ; Logvinov, L A ; Putilovskiy, M A ; Pushkar, D Yu ; Vasilevskiy, R P ; Akrikidi, A A ; Rasner, P I ; Skrupskiy, K S

INTRODUCTIONBenign prostatic hyperplasia (BPH) is one of the most common diseases in men over 50 years. The prevalence of the BPH increases with age, and pathologic features of BPH are found in about 90% of men over 80 years.AIMThe aim of the study was to study the efficacy and safety of Afalaza for the treatment of lower urinary tract symptoms (LUTS) in treatment-nave patients with BPH.MATERIALS AND METHODSA multicenter study of using Afalaza for the treatment of LUTS in treatment-nave patients with BPH was carried out in 9 urological centers in Moscow. A total of 80 treatment-nave patients with BPH were enrolled. The improvement in the total score of IPSS, IIEF-5 and QoL after 30 weeks of therapy was evaluated as well as changes in prostate volume and maximum urinary flow rate (Qmax).RESULTSAfter 30 weeks of therapy, there was a significant decrease in the total IPSS score. A decrease in the total IPSS score by 5.5 points (+37.9%) from 14.5+/-4.0 at the baseline to 9.0+/-4.1 at the visit 9 was seen. The QoL decreased by 1.8 (-38.3%) points from 4.7+/-1.0 at the baseline. The Qmax also changed from 12.7+/-4.6 to 16.4+/-5.7 (+28.3%) after 30 weeks of therapy. At the visit 9, the total IIEF5 score increased by 3.4+/-4.4 (+19.9%) from 17.1+/-4.3 at the baseline. In addition, prostate volume decreased from 42.7+/-11.1 at baseline to 41.0+/-9.8 cc post-treatment (-5.15%). A reduction of post-void residual urine volume from 26.0+/-25.3 at baseline to 17.7+/-24.2 (-31.9%) post-treatment was also shown.CONCLUSIONThe results of a multicenter study demonstrate the efficacy of Afalaza for treatment of treatment-nave patients with LUTS/BPH. Afalaza reduces prostate volume and improves an erectile function.

13 Mar 2018·Urologiia

Afalaza in the management of patients with chronic pelvic pain syndrome

Article

Author: Yu S Kondrateva ; N A Nozdrachev ; D O Arkhipov ; P A Oberemok ; D V Borisenko ; B A Neimark ; A I Neimark ; A A Makarova

INTRODUCTIONCurrently, chronic pelvic pain syndrome (CPPS) is one of the most prevalent urological diseases, but due to the multifactorial nature of the disease and the lack of consensus on its pathogenesis, the issue of adequate therapy remains open. Since the vascular factor plays the major role in the pathogenesis of CPPS, we hypothesized that this category of patients has microcirculatory disturbances of the prostate.AIMDetection of microcirculatory disturbances of the prostate, their correction, and evaluation of the effect on the course of CPPS.MATERIALS AND METHODSThe study comprised 60 healthy, sexually active men with clinical manifestations of CPPS lasting from 6 months to 5 years. After a comprehensive examination, all patients received Afalaza 2 tablets twice daily for 16 weeks. At the end of week 16, patients were re-examined.RESULTSIn patients with CPPS, therapy with Afalaza resulted in a significant improvement in microcirculation in the prostate thus leading to the reduction of the severity of disease manifestations.

100 Deals associated with Afalaza

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Hyperplasia	Phase 3	RU	OOO NPF Materia Medica Holding	01 Nov 2012
Prostatic Hyperplasia	Phase 3	UA	OOO NPF Materia Medica Holding	01 Nov 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2019	Not Applicable	Prostatic Hyperplasia	249	Afalaza	ysmunbgmfp(zwvanjvsxu) = sugyhvrlll vtbzwporeb (kqnwhgmkiu )	Positive	01 Apr 2019
NCT01716104 (CTgov)	Phase 3	Prostatic Hyperplasia	260	Afalaza (Afalaza)	kqnephwtcl(lfdjutbavd) = cynrinctbi evtkzstcey (ovinhovfwv, sxmptyyppc - ljdkhenncy) View more	-	09 Oct 2018
NCT01716104 (CTgov)	Phase 3	Prostatic Hyperplasia	260	Placebo (Placebo)	kqnephwtcl(lfdjutbavd) = vwwmpnasko evtkzstcey (ovinhovfwv, eejbxronjp - uphaelszua) View more	-	09 Oct 2018

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