Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003994

Trial Description

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Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine whether an experimental drug known as tadalafil
given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia
(straining, urinary frequency, feeling like your bladder is still full etc.)

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003994
  •   2013/01/10
  •   2009/09/01
  •   no
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Secondary IDs

  •   NCT00970632  (ClinicalTrials.gov)
  •   12932  (Eli Lilly and Company)
  •   H6D-MC-LVID 
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia (BPH)
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Tadalafil 5 mg
  •   Drug: Placebo tablet
  •   Drug: Tamsulosin
  •   Drug: Placebo capsule
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks; time frame: Baseline, 12 weeks; The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

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Secondary Outcome

- Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks; time frame: Baseline, 4 weeks; The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks; time frame: Baseline, 12 weeks; IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.; time frame: Baseline, 12 weeks; IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks; time frame: Baseline, 12 weeks; The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks; time frame: Baseline, 12 weeks; IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week; time frame: Baseline, 1 week; The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks; time frame: Baseline, 4 weeks; BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks; time frame: Baseline, 12 weeks; BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Patient Global Impression of Improvement (PGI-I) at 12 Weeks; time frame: 12 weeks; The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
- Clinician Global Impression of Improvement (CGI-I) at 12 Weeks; time frame: 12 weeks; The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".
- Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall; time frame: 12 weeks; The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.
- Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks; time frame: Baseline, 12 weeks; IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
- Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks; time frame: Baseline, 12 weeks; Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.
- Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks; time frame: Baseline, 12 weeks; Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.
- Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks; time frame: Baseline, 12 weeks; V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.
- Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks; time frame: Baseline, 12 weeks; PVR was the amount of urine remaining in the bladder after void completion.

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Countries of Recruitment

  •   Australia
  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Greece
  •   Italy
  •   Mexico
  •   Netherlands
  •   Poland
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Locations of Recruitment

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Recruitment

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  •   2009/10/31
  •   511
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   45   Years
  •   no maximum age
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Additional Inclusion Criteria

- Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to
as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the
start of study.

- Provide signed informed consent at the start of the study.

- Agree not to use any other approved or experimental pharmacologic BPH, overactive
bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.

- Have not taken finasteride therapy for at least 3 months before study drug is
dispensed and dutasteride therapy for at least 6 months before study drug is
dispensed.

- Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED
therapy for at least 4 weeks prior to study drug is dispensed.

- Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or
equal to 13 when study drug is dispensed.

- Have reduced urine flow (measured by special toilet equipment).

- Demonstrate compliance with study drug administration requirements.

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Exclusion Criteria

- Treated with nitrates

- Have unstable angina or angina that requires treatment.

- Have had any of the following in the past 90 days: Heart attack, also known as a
myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
or stent placement (percutaneous coronary intervention).

- Have very high or very low blood pressure.

- Have certain neurological conditions associated with bladder problems or injuries to
brain or spinal cord within a specified time of starting this study.

- Have uncontrolled diabetes.

- Have prostate cancer, are being treated for cancer.

- Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL)
at the start of study.

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Addresses

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    • Eli Lilly and Company
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    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) 
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    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2011/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.