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)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Vesomni
  Oral administration

Первичные конечные точки

• Number of Participants With Adverse Events (AEs) or Adverse Drug Reactions (ADR) [Срок оценки: Up to 24 Weeks]
• Number of Participants With Serious AE (SAE)/ Serious ADR (SADR) [Срок оценки: Up to 24 Weeks]
• Number of Participants With an Unexpected AE (UAE)/ Unexpected ADR (UADR) [Срок оценки: Up to 24 Weeks]
• Number of Participants With Important Risks [Срок оценки: Up to 24 Weeks]

Вторичные конечные точки (3)

• Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS) [Срок оценки: Baseline, Week 12 and 24]
• Change From Baseline in Storage Subscore of IPSS [Срок оценки: Baseline, Week 12 and 24]
• Change From Baseline in Quality of Life (QoL) Score of IPSS [Срок оценки: Baseline, Week 12 and 24]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07619105 · EC905-PV-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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