Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004069

Trial Description

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Title

A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to 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 investigate the efficacy and safety of once daily tadalafil
when taken with finasteride as a treatment for men with signs and symptoms of Benign
Prostatic Hyperplasia and demonstrable prostate enlargement.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004069
  •   2012/08/02
  •   2010/06/01
  •   no
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Secondary IDs

  •   NCT01139762  (ClinicalTrials.gov)
  •   13529  (Eli Lilly and Company)
  •   H6D-CR-LVIW 
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   Enlarged Prostate
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Tadalafil
  •   Drug: Placebo
  •   Drug: Finasteride
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks; time frame: Baseline, 12 weeks; The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

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Secondary Outcome

- Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks; time frame: Baseline, 4 weeks, 26 weeks; The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
- Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
- Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
- Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
- Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
- Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
- Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
- Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
- Patient Global Impression of Improvement (PGI-I) at 26 Weeks; time frame: 26 weeks; Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
- Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks; time frame: 26 weeks; The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.
- Clinician Global Impression of Improvement (CGI-I) at 26 Weeks; time frame: 26 weeks; Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
- Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks; time frame: Baseline, 26 weeks; Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.
- Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks; time frame: Baseline, 4 weeks, 12 weeks, 26 weeks; IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Belgium
  •   Brazil
  •   Canada
  •   France
  •   Germany
  •   Greece
  •   Italy
  •   Mexico
  •   Poland
  •   Russian Federation
  •   Turkey
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Locations of Recruitment

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Recruitment

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  •   2010/09/30
  •   646
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Have not taken the following treatments within the indicated duration and agree not
to use at any time during the study:

- All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal
preparations) for at least 4 weeks prior to receiving study medication.

- Overactive bladder therapy (including antimuscarinics) for at least 4 weeks
prior to receiving study medication.

- Erectile Dysfunction therapy (including herbal preparations) for at least 4
weeks prior to receiving study medication.

- Finasteride or dutasteride use at any time.

- Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of
greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second
before receiving study drug.

- Have prostate enlargement measured by ultrasound at screening.

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Exclusion Criteria

- Have prostate cancer, are being treated for cancer or have clinical evidence of
prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter
(ng/mL) at the start of study].

- 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 problems with kidneys, liver, or nervous system

- Have uncontrolled diabetes

- Have had a stroke or a significant injury to brain or spinal cord.

- Have scheduled or planned surgery during the course of the 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
  •   2012/05/01
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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.