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A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)

15. července 2026 aktualizováno: Astellas Pharma Korea, Inc.

Post-marketing Observational Study for Vesomni Modified Release Tablet 6 mg/0.4 mg (Solifenacin Succinate/Tamsulosin Hydrochloride) in Male Patients With Moderate to Severe Storage Symptoms and Voiding Symptoms Associated With BPH Who Are Not Adequately Responding to Treatment With Tamsulosin Monotherapy in South Korea

Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough.

This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate.

The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Primary data collection will occur during the observation period for each participant, targeted for 12 weeks (or at least 24 weeks for long-term users) after receiving the first dose of Vesomni. Secondary data collection (extracting data from medical records, including hospital admission/discharge notes, prescription drug files, biological measurements, etc.) will occur for participants enrolled.

Typ studie

Pozorovací

Zápis (Odhadovaný)

600

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Participants with moderate to severe storage symptoms (pollakiuria, micturition urgency) and voiding symptoms associated with BPH.

Popis

Inclusion Criteria:

  • A patient (adult male) who receives treatment with Vesomni, according to the approved local label during the registration period.

Exclusion Criteria:

  • A patient with any contraindication for Vesomni, according to the approved local label.
  • A patient who enrolled or is planning to enroll in any study of an investigational medicine during the observation period.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Vesomni
Participants who are not adequately responding to treatment with tamsulosin monotherapy who receive Vesomni modified release tablet 6 mg/0.4 mg in routine clinical practice according to the drug label approved at the time of marketing authorization.
Lék: Vesomni
Oral administration
Ostatní jména:
  • solifenacin succinate/tamsulosin hydrochloride

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR)
Časové okno: Up to 24 Weeks

An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.

An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.
Up to 24 Weeks
Number of Participants With Serious AE (SAE)/ Serious ADR (SADR)
Časové okno: Up to 24 Weeks
An AE is considered "serious" if it results in death or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction
Up to 24 Weeks
Number of Participants With an Unexpected AE (UAE)/ Unexpected ADR (UADR)
Časové okno: Up to 24 Weeks
An UAE is an AE that the nature or severity of which is not consistent with the information described in the approved Korean product label
Up to 24 Weeks
Number of Participants With Important Risks
Časové okno: Up to 24 Weeks

An important risk is classified as either an important identified risk and/or an important potential risk.

An "Important Identified Risk" refers to an undesirable clinical outcome, with sufficient scientific evidence through clinical trials or post-marketing data to confirm that the undesirable clinical outcome is caused by the drug, and which have the potential to affect the risk-benefit balance of a product.

An "Important Potential Risk" refers to an undesirable clinical outcome, with some, but not sufficient, evidence to confirm that the undesirable clinical outcome is caused by the drug. These risks may have the potential to affect the risk-benefit balance of a product, and therefore require ongoing monitoring and assessment.
Up to 24 Weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)
Časové okno: Baseline, Week 12 and 24
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. Each of the 7 symptom questions is scored from 0 to 5, indicating increasing severity of the symptom, with a total score ranging from 0 to 35.
Baseline, Week 12 and 24
Change From Baseline in Storage Subscore of IPSS
Časové okno: Baseline, Week 12 and 24
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. The storage sub-score of the IPSS, which is calculated from the frequency, urgency, and nocturia sections of the IPSS total score, is used to evaluate the degree of urinary storage symptoms related to BPH. Each question in the storage sub-score is scored from 0 to 5, indicating increasing severity of the symptom, with a total score range from 0 to 15.
Baseline, Week 12 and 24
Change From Baseline in Quality of Life (QoL) Score of IPSS
Časové okno: Baseline, Week 12 and 24
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL. The QoL question is scored separately on a scale from 0 (delighted) to 6 (terrible), reflecting the patient's subjective satisfaction with their urinary condition.
Baseline, Week 12 and 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Astellas Pharma Korea, Inc.

Vyšetřovatelé

  • Ředitel studie: Central Contact, Astellas Pharma Korea, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. září 2026

Primární dokončení (Odhadovaný)

30. listopadu 2030

Dokončení studie (Odhadovaný)

30. listopadu 2030

Termíny zápisu do studia

První předloženo

26. května 2026

První předloženo, které splnilo kritéria kontroly kvality

26. května 2026

První zveřejněno (Aktuální)

1. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • EC905-PV-0001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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