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Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

18 maart 2011 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

422

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Japan
      • 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.
      • 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.
      • 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.
      • 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.
      • 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.
      • 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.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Tadalafil 2.5 mg
oral, daily
Andere namen:
  • LY450190
  • Cialis
Experimenteel: 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.
Geneesmiddel: Tadalafil 5 mg
oral, daily
Andere namen:
  • LY450190
  • Cialis
Placebo-vergelijker: 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.
Geneesmiddel: Placebo
oral, daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Tijdsspanne: 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.
Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
Tijdsspanne: 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
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Tijdsspanne: Baseline, 12 weeks
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Baseline, 12 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
Tijdsspanne: 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.
Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Tijdsspanne: Baseline, 12 weeks
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Baseline, 12 weeks
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Tijdsspanne: Baseline, 12 weeks
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Baseline, 12 weeks
Number of Participants With Adverse Events During 12 Weeks of the Study
Tijdsspanne: Baseline through 12 weeks
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Baseline through 12 weeks
Change From Baseline in Blood Pressure at 12-Week Endpoint
Tijdsspanne: Baseline, 12 weeks
Baseline, 12 weeks
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Tijdsspanne: Baseline, 12 Weeks
Baseline, 12 Weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Tijdsspanne: Baseline, 12 weeks
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Baseline, 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Tijdsspanne: Baseline, 12 weeks
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Baseline, 12 weeks
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
Tijdsspanne: 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
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
Tijdsspanne: 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
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Tijdsspanne: End of 12 weeks of double-blind through 54 weeks
A listing of Adverse Events are reported in the Reported Adverse Event Section.
End of 12 weeks of double-blind through 54 weeks
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Tijdsspanne: Baseline, 54 weeks
Baseline, 54 weeks
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Tijdsspanne: Baseline, 54-weeks
Baseline, 54-weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Tijdsspanne: 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
Tijdsspanne: Baseline, 54 weeks
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Baseline, 54 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2008

Primaire voltooiing (Werkelijk)

1 juni 2009

Studie voltooiing (Werkelijk)

1 april 2010

Studieregistratiedata

Eerst ingediend

30 oktober 2008

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2008

Eerst geplaatst (Schatting)

31 oktober 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

29 maart 2011

Laatste update ingediend die voldeed aan QC-criteria

18 maart 2011

Laatst geverifieerd

1 maart 2011

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 12757
  • H6D-JE-LVIA (Andere identificatie: Eli Lilly and Company)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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