Trial to Evaluate the Efficacy and Safety of HCP1302

Phase 3

Completed

• Conditions: Erectile Dysfunction; Hypertension
• Interventions: Drug: HCP1302; Drug: HGP0904; Drug: Placebo (for HCP1302); Drug: Placebo (for HGP0904)

• Registration Number: NCT02587988
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 232

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCP1302Placebo+HGP0904	Placebo (for HCP1302)	HCP1302Placebo+HGP0904 for 12weeks
HCP1302+HGP0904Placebo	Placebo (for HGP0904)	HCP1302+HGP0904Placebo for 12weeks
HCP1302+HGP0904Placebo	HCP1302	HCP1302+HGP0904Placebo for 12weeks
HCP1302Placebo+HGP0904	HGP0904	HCP1302Placebo+HGP0904 for 12weeks

Primary Outcome Measures

Name	Time	Method
Change of IIEF-EF domain score	baseline and 12 weeks
Change of sitting diastolic blood pressure	baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change of sitting diastolic blood pressure	baseline, 4weeks and 8weeks
Change of IIEF-EF domain score	baseline, 4weeks and 8weeks
Change of sitting systolic blood pressure	baseline,4weeks, 8weeks and 12 weeks