Trial to Evaluate the Efficacy and Safety of HCP1302

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Trial to Evaluate the Efficacy and Safety of HCP1302

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

At Visit1

1. ≥19 age

2. Hypertension Patients who need amlodipine 5mg

3. Abnormal Erectile function ≥ at least 3months based on screening date

4. Patients who are expected to frequent use of Tadalafil (at least two times for weeks)

5. Patients understood the consents and purpose of this trial and signed informed consent form

At Visit2

1. 90≤ sitSBP < 140 mmHg and 50 ≤ sitDBP < 90 mmHg

2. Sexual dysfunction rate ≥ 50% for 4 weeks run-in period

3. International Index of Erectile Function(IIEF)- Erectile Function(EF) domain score ≤ 25

Exclusion Criteria:

1. History of hypersensitivity to Amlodipine or Tadalafil

2. Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range

3. Has a clinically significant renal failure (Scr > 2mg/dl)

4. Uncontrolled diabetes mellitus (HbA1C >12%)

5. At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg

6. Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date

7. No reaction to PDE-5 inhibitors