NCT02587988

Brief Summary

Trial to Evaluate the Efficacy and Safety of HCP1302

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

October 25, 2015

Last Update Submit

October 31, 2016

Conditions

Erectile DysfunctionHypertension

Keywords

Erectile dysfunction & Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change of IIEF-EF domain score

    baseline and 12 weeks

  • Change of sitting diastolic blood pressure

    baseline and 12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

HCP1302+HGP0904Placebo

EXPERIMENTAL

HCP1302+HGP0904Placebo for 12weeks

Drug: HCP1302Drug: Placebo (for HGP0904)

HCP1302Placebo+HGP0904

ACTIVE COMPARATOR

HCP1302Placebo+HGP0904 for 12weeks

Drug: HGP0904Drug: Placebo (for HCP1302)

Interventions

HCP1302DRUG
HCP1302+HGP0904Placebo
HGP0904DRUG
HCP1302Placebo+HGP0904
Placebo (for HCP1302)DRUG
HCP1302Placebo+HGP0904
Placebo (for HGP0904)DRUG
HCP1302+HGP0904Placebo

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • History of hypersensitivity to Amlodipine or Tadalafil
  • Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
  • Has a clinically significant renal failure (Scr \> 2mg/dl)
  • Uncontrolled diabetes mellitus (HbA1C \>12%)
  • At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
  • Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
  • No reaction to PDE-5 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile DysfunctionHypertension

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2015

First Posted

October 27, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share