Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
18. března 2011 aktualizováno: Eli Lilly and Company
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
422
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Chiba, Japonsko, 274-0825
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hiroshima, Japonsko, 730-0013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa, Japonsko, 226-0025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyoto, Japonsko, 607-8085
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japonsko, 561-0832
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Japonsko, 150-0002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
45 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
Inclusion Criteria:
- Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
- Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
- Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.
Exclusion Criteria:
- Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
- History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
- Clinical evidence of prostate cancer at Visit 1.
- Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
- History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
- History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
- Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
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
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Tadalafil 2.5 milligrams (mg)
2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
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oral, daily
Ostatní jména:
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Experimentální: Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
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oral, daily
Ostatní jména:
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Komparátor placeba: Placebo
Placebo tablet taken by mouth once a day for 12 weeks. Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks. |
oral, daily
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions.
Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
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Baseline, 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire.
Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
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Baseline, 12 weeks
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire.
Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
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Baseline, 12 weeks
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Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
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Baseline, 12 weeks
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Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence.
Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
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Baseline, 12 weeks
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Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
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Baseline, 12 weeks
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Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Časové okno: Baseline, 12 weeks
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Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
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Baseline, 12 weeks
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Number of Participants With Adverse Events During 12 Weeks of the Study
Časové okno: Baseline through 12 weeks
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A listing of Adverse Events are reported in the Reported Adverse Event Section.
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Baseline through 12 weeks
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Change From Baseline in Blood Pressure at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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Baseline, 12 weeks
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Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Časové okno: Baseline, 12 Weeks
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Baseline, 12 Weeks
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Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
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Baseline, 12 weeks
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Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Časové okno: Baseline, 12 weeks
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Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
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Baseline, 12 weeks
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Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions.
Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
|
Baseline, 54 weeks
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire.
Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
|
Baseline, 54 weeks
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
|
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire.
Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
|
Baseline, 54 weeks
|
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Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
|
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
|
Baseline, 54 weeks
|
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Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
|
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence.
Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
|
Baseline, 54 weeks
|
|
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
|
Baseline, 54 weeks
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Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Časové okno: End of 12 weeks of double-blind through 54 weeks
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A listing of Adverse Events are reported in the Reported Adverse Event Section.
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End of 12 weeks of double-blind through 54 weeks
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Change From Baseline in Blood Pressure During at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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Baseline, 54 weeks
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Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Časové okno: Baseline, 54-weeks
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Baseline, 54-weeks
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Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
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Baseline, 54 weeks
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Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Časové okno: Baseline, 54 weeks
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Post residual volume (PVR) is measured by ultrasound at regular intervals.
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Baseline, 54 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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
1. listopadu 2008
Primární dokončení (Aktuální)
1. června 2009
Dokončení studie (Aktuální)
1. dubna 2010
Termíny zápisu do studia
První předloženo
30. října 2008
První předloženo, které splnilo kritéria kontroly kvality
30. října 2008
První zveřejněno (Odhad)
31. října 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
29. března 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. března 2011
Naposledy ověřeno
1. března 2011
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12757
- H6D-JE-LVIA (Jiný identifikátor: Eli Lilly and Company)
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 .