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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

NCT ID: NCT00848081

Last Updated: 2010-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

By mouth once daily for 12 weeks

Tadalafil

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

5 mg taken by mouth once daily for 12 weeks

Interventions

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Tadalafil

5 mg taken by mouth once daily for 12 weeks

Intervention Type DRUG

Placebo

By mouth once daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis

Eligibility Criteria

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Inclusion Criteria

* Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria

* Currently receiving alpha-blocker therapy for the treatment of hypertension.
* History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
* Treated with nitrates for any cardiac conditions.
* 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 prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
* Have had a stroke or a significant injury to brain or spinal cord.
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 hourse, 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

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.

Anchorage, Alaska, United States

Site Status

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Anaheim, California, United States

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Los Angeles, California, United States

Site Status

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Paramount, California, United States

Site Status

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San Diego, California, United States

Site Status

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Vacaville, California, United States

Site Status

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Melbourne, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Indianapolis, Indiana, United States

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Saint Clair Shores, Michigan, United States

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Missoula, Montana, United States

Site Status

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Albuquerque, New Mexico, United States

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Bay Shore, New York, United States

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Garden City, New York, United States

Site Status

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New York, New York, United States

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Poughkeepsie, New York, United States

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Concord, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Edmond, Oklahoma, United States

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Dallas, Texas, United States

Site Status

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San Antonio, Texas, United States

Site Status

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Salt Lake City, Utah, United States

Site Status

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Menomonee Falls, Wisconsin, United States

Site Status

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Bayamón, , Puerto Rico

Site Status

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San Juan, , Puerto Rico

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.

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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H6D-MC-LVHS

Identifier Type: OTHER

Identifier Source: secondary_id

11668

Identifier Type: -

Identifier Source: org_study_id