Trial to Evaluate the Efficacy and Safety of HCP1302

A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904

At Visit1

• ≥19 age
• Hypertension Patients who need amlodipine 5mg
• Abnormal Erectile function ≥ at least 3months based on screening date
• Patients who are expected to frequent use of Tadalafil (at least two times for weeks)
• Patients understood the consents and purpose of this trial and signed informed consent form

At Visit2

• 90≤ sitSBP < 140 mmHg and 50 ≤ sitDBP < 90 mmHg
• Sexual dysfunction rate ≥ 50% for 4 weeks run-in period
• International Index of Erectile Function(IIEF)- Erectile Function(EF) domain score ≤ 25

Exclusion criteria

• History of hypersensitivity to Amlodipine or Tadalafil
• Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
• Has a clinically significant renal failure (Scr > 2mg/dl)
• Uncontrolled diabetes mellitus (HbA1C >12%)
• At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
• Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
• No reaction to PDE-5 inhibitors