Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
18. März 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
422
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Chiba, Japan, 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, Japan, 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, Japan, 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, Japan, 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, Japan, 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, Japan, 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
45 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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
Andere Namen:
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Experimental: 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
Andere Namen:
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Placebo-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2008
Primärer Abschluss (Tatsächlich)
1. Juni 2009
Studienabschluss (Tatsächlich)
1. April 2010
Studienanmeldedaten
Zuerst eingereicht
30. Oktober 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. Oktober 2008
Zuerst gepostet (Schätzen)
31. Oktober 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. März 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. März 2011
Zuletzt verifiziert
1. März 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12757
- H6D-JE-LVIA (Andere Kennung: Eli Lilly and Company)
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