Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

Inclusion criteria

[Visit 1]

• Male Aged of 45 or above
• Patients must have a diagnosis of Benign Prostatic Hyperplasia
• IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
• Signed and dated informed consent document indicating that the patient

[Visit 2]

• IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
• 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
• PVR(post-void residual urine volume) ≤ 250ml

Exclusion criteria

• Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
• Patients with prostate cancer or PSA > 10ng/ml
• Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
• Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
• Patients with acute urinary retention in 3months
• Patients with a history of drug or alcohol abuse within 6 months
• Patients have cardiovascular disease or associated disease which is not controlled.
• Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
• Patients with orthostatic hypotension
• Patients with a history micturition syncope
• Patients with severe or malignant retinopathy
• Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
• Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3
• Patient with uncontrolled diabetes(HbA1C>9%)
• Patients have a history of malignant tumor within 5 years
• Patients have hypersensitivity reaction on this drug.
• Patients treated with other investigational product within 4 weeks at first time taking the investigational product
• Not eligible to participate for the study at the discretion of investigator