Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.


Options:
A: Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
B: Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation
* Medical conditions in which it would be unsafe to use an alpha-blocker
* Use of concomitant drugs that would confound the efficacy evaluation
* Use of concomitant drugs that would be unsafe with this alpha-blocker
C: 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.

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.
D: Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.

Answer: A