Trial to Evaluate the Efficacy and Safety of HCP1302
Primary Purpose
Erectile Dysfunction, Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HCP1302
HGP0904
Placebo (for HCP1302)
Placebo (for HGP0904)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction & Hypertension
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HCP1302+HGP0904Placebo
HCP1302Placebo+HGP0904
Arm Description
HCP1302+HGP0904Placebo for 12weeks
HCP1302Placebo+HGP0904 for 12weeks
Outcomes
Primary Outcome Measures
Change of IIEF-EF domain score
Change of sitting diastolic blood pressure
Secondary Outcome Measures
Change of sitting diastolic blood pressure
Change of sitting systolic blood pressure
Change of IIEF-EF domain score
Full Information
NCT ID
NCT02587988
First Posted
October 25, 2015
Last Updated
October 31, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02587988
Brief Title
Trial to Evaluate the Efficacy and Safety of HCP1302
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Hypertension
Keywords
Erectile dysfunction & Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCP1302+HGP0904Placebo
Arm Type
Experimental
Arm Description
HCP1302+HGP0904Placebo for 12weeks
Arm Title
HCP1302Placebo+HGP0904
Arm Type
Active Comparator
Arm Description
HCP1302Placebo+HGP0904 for 12weeks
Intervention Type
Drug
Intervention Name(s)
HCP1302
Intervention Type
Drug
Intervention Name(s)
HGP0904
Intervention Type
Drug
Intervention Name(s)
Placebo (for HCP1302)
Intervention Type
Drug
Intervention Name(s)
Placebo (for HGP0904)
Primary Outcome Measure Information:
Title
Change of IIEF-EF domain score
Time Frame
baseline and 12 weeks
Title
Change of sitting diastolic blood pressure
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change of sitting diastolic blood pressure
Time Frame
baseline, 4weeks and 8weeks
Title
Change of sitting systolic blood pressure
Time Frame
baseline,4weeks, 8weeks and 12 weeks
Title
Change of IIEF-EF domain score
Time Frame
baseline, 4weeks and 8weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial to Evaluate the Efficacy and Safety of HCP1302
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