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Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

NCT ID: NCT00827242

Last Updated: 2010-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

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.)

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Keywords

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Signs and Symptoms Prostatic Hyperplasia Hyperplasia Genital Diseases, Male Prostatic Diseases BPH-LUTS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tadalafil

Group Type EXPERIMENTAL

tadalafil

Intervention Type DRUG

Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.

Interventions

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Placebo

Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.

Intervention Type DRUG

tadalafil

Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.

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-LUTS \[lower urinary tract symptoms\] based on the disease diagnostic criteria at the start of study.
* Provide signed informed consent at the start of 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), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
* Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
* Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
* Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
* Demonstrate compliance with study drug administration requirements.

Exclusion Criteria

* Treated with nitrates for a cardiac conditions.
* 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 problems with kidneys, liver, or nervous system.
* Have uncontrolled diabetes.
* Have had a stroke or a significant injury to brain or spinal cord.
* 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).
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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Eli Lilly

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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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.

Huntsville, Alabama, United States

Site Status

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Middlebury, Connecticut, United States

Site Status

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.

Sarasota, Florida, United States

Site Status

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.

Roswell, Georgia, United States

Site Status

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Chicago, Illinois, United States

Site Status

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Bay Shore, New York, United States

Site Status

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New York, New York, United States

Site Status

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Williamsville, New York, United States

Site Status

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Durham, North Carolina, United States

Site Status

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Columbus, Ohio, United States

Site Status

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Knoxville, Tennessee, United States

Site Status

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Virginia Beach, Virginia, United States

Site Status

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.

Buenos Aires, , Argentina

Site Status

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Berlin, , Germany

Site Status

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Hamburg, , Germany

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Marburg, , Germany

Site Status

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Mühlacker, , Germany

Site Status

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Oranienburg, , Germany

Site Status

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Bergamo, , Italy

Site Status

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Milan, , Italy

Site Status

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Napoli, , Italy

Site Status

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Orbassano, , Italy

Site Status

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Rome, , Italy

Site Status

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Mexico City, , Mexico

Site Status

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.

Monterrey, , Mexico

Site Status

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.

Saltillo, , Mexico

Site Status

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Zapopan, , Mexico

Site Status

Countries

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United States Argentina Germany Italy Mexico

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
PMID: 26299520 (View on PubMed)

Porst H, Kim ED, Casabe AR, Mirone V, Secrest RJ, Xu L, Sundin DP, Viktrup L; LVHJ study team. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011 Nov;60(5):1105-13. doi: 10.1016/j.eururo.2011.08.005. Epub 2011 Aug 12.

Reference Type DERIVED
PMID: 21871706 (View on PubMed)

Other Identifiers

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H6D-MC-LVHJ

Identifier Type: OTHER

Identifier Source: secondary_id

10893

Identifier Type: -

Identifier Source: org_study_id