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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02587988
Other study ID # HM-TARO-301
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2015
Last updated October 31, 2016
Start date September 2014
Est. completion date August 2015

Study information

Verified date October 2016
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

Trial to Evaluate the Efficacy and Safety of HCP1302


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


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date August 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
HCP1302

HGP0904

Placebo (for HCP1302)

Placebo (for HGP0904)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type Measure Description Time frame Safety issue
Primary Change of IIEF-EF domain score baseline and 12 weeks No
Primary Change of sitting diastolic blood pressure baseline and 12 weeks No
Secondary Change of sitting diastolic blood pressure baseline, 4weeks and 8weeks No
Secondary Change of sitting systolic blood pressure baseline,4weeks, 8weeks and 12 weeks No
Secondary Change of IIEF-EF domain score baseline, 4weeks and 8weeks No
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