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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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

600

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Arzneimittel: Vesomni
Oral administration
Andere Namen:
  • solifenacin succinate/tamsulosin hydrochloride

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Astellas Pharma Korea, Inc.

Ermittler

  • Studienleiter: Central Contact, Astellas Pharma Korea, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. September 2026

Primärer Abschluss (Geschätzt)

30. November 2030

Studienabschluss (Geschätzt)

30. November 2030

Studienanmeldedaten

Zuerst eingereicht

26. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EC905-PV-0001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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/.

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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