A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
NCT ID: NCT00970632
Last Updated: 2012-03-12
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
511 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-10-31
Study Completion Date
2011-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Benign Prostatic Hyperplasia (BPH)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Placebo
Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks
Group Type
PLACEBO_COMPARATOR
Placebo tablet
Intervention Type
DRUG
Placebo tablet po QD for 12 weeks
Placebo capsule
Intervention Type
DRUG
Placebo capsule po QD for 12 weeks
Tadalafil 5 milligram (mg)
Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks
Group Type
EXPERIMENTAL
Tadalafil 5 mg
Intervention Type
DRUG
Tadalafil 5 mg po QD for 12 weeks
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
Group Type
ACTIVE_COMPARATOR
Tamsulosin
Intervention Type
DRUG
Tamsulosin 0.4 mg po QD for 12 weeks
Interventions
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Tadalafil 5 mg
Tadalafil 5 mg po QD for 12 weeks
Intervention Type
DRUG
Placebo tablet
Placebo tablet po QD for 12 weeks
Intervention Type
DRUG
Tamsulosin
Tamsulosin 0.4 mg po QD for 12 weeks
Intervention Type
DRUG
Placebo capsule
Placebo capsule po QD for 12 weeks
Intervention Type
DRUG
Other Intervention Names
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Cialis
LY450190
Eligibility Criteria
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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.
* 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.
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.
* 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.
Minimum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Adelaide, South Australia, Australia
Site Status
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Bentleigh East, Victoria, Australia
Site Status
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Bunbury, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Garches, , France
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Nice, , France
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Orléans, , France
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Paris, , France
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Pierre-Bénite, , France
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Suresnes, , France
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Bad Rappenau, , Germany
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Bad Wiessee, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Mühlacker, , Germany
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Oranienburg, , Germany
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Heraklion, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Bergamo, , Italy
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Cagliari, , Italy
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Florence, , Italy
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Napoli, , Italy
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Sassari, , Italy
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Monterrey, , Mexico
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Morelia, , Mexico
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Saltillo, , Mexico
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Zapopan, , Mexico
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's-Hertogenbosch, , Netherlands
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Arnhem, , Netherlands
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Breda, , Netherlands
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Tilburg, , Netherlands
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Veldhoven, , Netherlands
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Bialystok, , Poland
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Kutno, , Poland
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Warsaw, , Poland
Site Status
Countries
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Australia
Austria
Belgium
France
Germany
Greece
Italy
Mexico
Netherlands
Poland
References
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Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
Reference Type
DERIVED
Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.
Reference Type
DERIVED
Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.
Reference Type
DERIVED
Other Identifiers
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H6D-MC-LVID
Identifier Type: OTHER
Identifier Source: secondary_id
12932
Identifier Type: -
Identifier Source: org_study_id
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