Erectile Dysfunction, Hypertension
Conditions
Keywords
Erectile dysfunction & Hypertension
Brief summary
Trial to Evaluate the Efficacy and Safety of HCP1302
Detailed description
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
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of IIEF-EF domain score | baseline and 12 weeks |
| Change of sitting diastolic blood pressure | baseline and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change of sitting diastolic blood pressure | baseline, 4weeks and 8weeks |
| Change of sitting systolic blood pressure | baseline,4weeks, 8weeks and 12 weeks |
| Change of IIEF-EF domain score | baseline, 4weeks and 8weeks |
Outcome results
None listed