Trial to Evaluate the Efficacy and Safety of HCP1302

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

Trial to Evaluate the Efficacy and Safety of HCP1302

Study Overview

• Status: Completed
• Conditions: Hypertension; Erectile Dysfunction
• Intervention / Treatment: Drug: HGP0904; Drug: HCP1302; Drug: Placebo (for HGP0904); Drug: Placebo (for 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

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HCP1302+HGP0904Placebo; HCP1302+HGP0904Placebo for 12weeks	Drug: HCP1302; Drug: Placebo (for HGP0904)
ACTIVE_COMPARATOR: HCP1302Placebo+HGP0904; HCP1302Placebo+HGP0904 for 12weeks	Drug: HGP0904; Drug: Placebo (for HCP1302)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: October 25, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (ESTIMATE): October 27, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Erectile dysfunction & Hypertension
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Hypertension; Erectile Dysfunction
• Other Study ID Numbers: HM-TARO-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO