Trial to Evaluate the Efficacy and Safety of HCP1302

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587988
• Other study ID #: HM-TARO-301
• 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

• Erectile Dysfunction
• Hypertension

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