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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)

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction & Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

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

Learn more about this trial

Trial to Evaluate the Efficacy and Safety of HCP1302

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