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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy

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).

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.