Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
18 marca 2011 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
422
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Chiba, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
45 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Męski
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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
Inne nazwy:
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Eksperymentalny: 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
Inne nazwy:
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Komparator placebo: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline, 54 weeks
|
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, 54 weeks
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Ramy czasowe: 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
Ramy czasowe: Baseline, 54 weeks
|
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
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Baseline, 54 weeks
|
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Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
Ramy czasowe: 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
|
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Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Ramy czasowe: Baseline, 54 weeks
|
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, 54 weeks
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Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2008
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2009
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2010
Daty rejestracji na studia
Pierwszy przesłany
30 października 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
30 października 2008
Pierwszy wysłany (Oszacować)
31 października 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
29 marca 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 marca 2011
Ostatnia weryfikacja
1 marca 2011
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 12757
- H6D-JE-LVIA (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .