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