Trial to Evaluate the Efficacy and Safety of HCP1302

Study Overview
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Brief Summary
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Trial to Evaluate the Efficacy and Safety of HCP1302

Detailed Description
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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

Official Title
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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

Conditions
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Erectile Dysfunction, Hypertension

Intervention / Treatment
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* Drug: HCP1302
* Drug: HGP0904
* Drug: Placebo (for HCP1302)
* Drug: Placebo (for HGP0904)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP1302+HGP0904Placebo<br>HCP1302+HGP0904Placebo for 12weeks | Drug: HCP1302<br> <br> Drug: Placebo (for HGP0904)<br> <br> |
| Active Comparator: HCP1302Placebo+HGP0904<br>HCP1302Placebo+HGP0904 for 12weeks | Drug: HGP0904<br> <br> Drug: Placebo (for HCP1302)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IIEF-EF domain score |  | baseline and 12 weeks | 
| Change of sitting diastolic blood pressure |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction & Hypertension