Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System (CV)
Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
Aperçu de l'étude
Statut
Les conditions
Description détaillée
BPH and hypertension are chronic senile diseases that increase in prevalence with age. It is reported that 25% of men over 60 years old suffer from both BPH and hypertension. Though these two diseases differ in nature, there is a hypothesis advanced from recent studies that for both diseases, increase in sympathetic tone plays an important role in pathophysiology.
As a medical treatment of BPH, α-blockers are widely selected in clinical studies as a first line treatment in patients with LUTS, for its non-invasiveness and superior clinical efficacy [1, 5]. Such α-blockers increases urine flow and decreases residual urine by controlling excitement of the sympathetic nervous system distributed around smooth muscle of prostate and bladder neck. Through this, α-blockers improve conditions of clinical symptoms of patients suffering from LUTS due to BPH, and decrease need for invasive surgery related to BPH, and also have medical action to decrease morbidity rate of secondary complications of BPH such as acute retention of urine, deterioration of renal function, bladder stone and urinary tract infection.
However, in the case of patients who are on hypertension medication, when considering concomitant administration with α-blockers, adverse events such as orthostatic hypotension and dizziness due to drop in blood pressure is most concerned. In this regard, silodosin, as an alpha 1A adrenoceptor antagonist, has been proven have low occurrence of adverse events related to cardiovascular system and have little effect on blood pressure compared to other α-blockers.
Thus, in this study, we aim to see the effect on cardiovascular system(blood pressure) Thrupas® capsule is administered every day for 12 weeks in patients with LUTS suggestive of BPH.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Seoul, Corée, République de, 138-736
- Asan Medical Center
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Seoul, Corée, République de, 137-701
- Seoul St. Mary's Hospital of the Catholic University of Korea
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Seoul, Corée, République de, 135-720
- Gangam Severance Hospital
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Corée, République de, 431-796
- Hallym University Sacred Heart Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The number of study subjects was calculated based on safety end-point which was variable change in SBP measurement before and after the administration of Silodosin. In previous studies, the standard deviation in before and after administration of Silodosin was 12.81. Therefore, this study assumed the standard deviation in before and after administration to be 12.81.
When the significance level was 0.05, the confidence interval was 1.41 and standard deviation of SBP measurement before and after the administration of Silodocsin was 12.81, the standard sample size will be 318 people and target number of study subject will be 400 as the expected drop rate is 20%.
La description
Inclusion Criteria:
Patients who have been diagnosed with BPH by digital rectal exam or ultrasonographic findings and meet the following criteria.
- Male, 50 years or older
- Patients with a total I-PSS score ≥ 8
- Patients with a QoL score ≥ 3
- Patients who voluntarily decided to participate and have filled out consent form
Exclusion Criteria:
- Patients with an allergy to α-blockers
- Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Patients with severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma)
- Patients with renal dysfunction
- Has PSA value ≥ 10ng/ml or has been diagnosed with tumor by biopsy even if PSA value is lower than 10ng/ml,
- Patients with history of prostate surgery
- Patients previously administered with 5α-reductase inhibitor within 3 months
- Patients previously administered with α1-adrenoceptor antagonist within 1 month
- Patients who are taking the following drugs at the start of study or those who have to take during the 12 weeks of the study: αβ-adrenoceptor antagonist, α-adrenoceptor agonist, anticholinergic (tolterodine, oxybutynin, etc.)
- Patients with a history of intrapelvic radiation therapy or prostatic hyperthermia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in blood pressure (systolic, diastolic) before and after administration
Délai: 3 months
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3 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Événements indésirables
Délai: 3 mois
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3 mois
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Change in IPSS total score before and after administration*
Délai: 3 months
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3 months
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Change in QoL score before and after administration
Délai: 3 months
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3 months
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Change in IPSS subscore before and after administration
Délai: 3 months
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3 months
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Evaluation of BSW after administration
Délai: 3 months
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3 months
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Change in Qmax before and after administration
Délai: 3 months
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3 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JWP-SDS-405
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