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Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384930
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : August 19, 2009
Last Update Posted : September 2, 2009
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 3, 2006
First Posted Date  ICMJE October 6, 2006
Results First Submitted Date  ICMJE October 17, 2008
Results First Posted Date  ICMJE August 19, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
  • Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis [ Time Frame: Baseline and 12 weeks ]
    Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
  • Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis [ Time Frame: Baseline and 12 weeks ]
    Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
Tadalafil for 12 weeks is superior to placebo in improving the International Prostate Symptom Score (IPSS) in men with signs and symptoms of benign prostatic hyperplasia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
  • Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore [ Time Frame: baseline and 12 weeks ]
    Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
  • Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: 12 weeks ]
    Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
  • Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) [ Time Frame: baseline and 12 weeks ]
    Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).
  • Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: baseline and 12 weeks ]
    Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
  • Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline and 12 weeks ]
    Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.
  • Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) [ Time Frame: 12 weeks ]
    LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.
  • Change From Baseline to 12 Week Endpoint in Peak Urinary Flow [ Time Frame: baseline and 12 weeks ]
    Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.
  • Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain [ Time Frame: baseline and 12 weeks ]
    Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
Tadalafil superior to placebo in improvement of selected IPSS subdomains and in uroflowmetry. Safety will also be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: tadalafil
    2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    5 mg tadalafil tablet by mouth once a day for twelve weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    10 mg tadalafil tablet by mouth once a day for twelve weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: tadalafil
    20 mg tadalafil tablet by mouth once a day for twelve weeks.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: placebo
    Placebo tablet taken by mouth one a day for twelve weeks
Study Arms  ICMJE
  • Placebo Comparator: 1
    placebo tablet
    Intervention: Drug: placebo
  • Active Comparator: 2
    2.5 mg tadalafil tablet
    Intervention: Drug: tadalafil
  • Active Comparator: 3
    5 mg tadalafil tablet
    Intervention: Drug: tadalafil
  • Active Comparator: 4
    10 mg tadalafil tablet
    Intervention: Drug: tadalafil
  • Active Comparator: 5
    20 mg tadalafil tablet
    Intervention: Drug: tadalafil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2009)
1058
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms 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 approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
  • Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
  • Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

Exclusion Criteria:

  • History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
  • History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
  • History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
  • Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
  • Nitrate use
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Canada,   Mexico
 
Administrative Information
NCT Number  ICMJE NCT00384930
Other Study ID Numbers  ICMJE 9797
H6D-MC-LVHG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE ICOS Corporation
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP