Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
18 marzo 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
422
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Chiba, Giappone, 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, Giappone, 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, Giappone, 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, Giappone, 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, Giappone, 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, Giappone, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
45 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Sperimentale: 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
Altri nomi:
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Comparatore 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Lasso di tempo: Baseline, 12 weeks
|
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, 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Lasso di tempo: Baseline, 12 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, 12 weeks
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
Lasso di tempo: Baseline, 12 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, 12 weeks
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Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Lasso di tempo: Baseline, 12 weeks
|
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
Lasso di tempo: Baseline, 12 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.
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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
Lasso di tempo: Baseline, 12 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, 12 weeks
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Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Lasso di tempo: Baseline, 12 weeks
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 12 Weeks
|
Baseline, 12 Weeks
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Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 54 weeks
|
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
Lasso di tempo: 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.
|
Baseline, 54 weeks
|
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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Lasso di tempo: 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
|
|
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Lasso di tempo: Baseline, 54 weeks
|
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
|
Baseline, 54 weeks
|
|
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
Lasso di tempo: 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
Lasso di tempo: Baseline, 54 weeks
|
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
Lasso di tempo: End of 12 weeks of double-blind through 54 weeks
|
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
Lasso di tempo: 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
Lasso di tempo: Baseline, 54-weeks
|
Baseline, 54-weeks
|
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Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Lasso di tempo: Baseline, 54 weeks
|
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
|
Baseline, 54 weeks
|
|
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Lasso di tempo: Baseline, 54 weeks
|
Post residual volume (PVR) is measured by ultrasound at regular intervals.
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Baseline, 54 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2008
Completamento primario (Effettivo)
1 giugno 2009
Completamento dello studio (Effettivo)
1 aprile 2010
Date di iscrizione allo studio
Primo inviato
30 ottobre 2008
Primo inviato che soddisfa i criteri di controllo qualità
30 ottobre 2008
Primo Inserito (Stima)
31 ottobre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
29 marzo 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 marzo 2011
Ultimo verificato
1 marzo 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12757
- H6D-JE-LVIA (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .