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Trial to Evaluate the Efficacy and Safety of HCP1302

NCT ID: NCT02587988

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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Trial to Evaluate the Efficacy and Safety of HCP1302

Detailed Description

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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

Conditions

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Erectile Dysfunction Hypertension

Keywords

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Erectile dysfunction & Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HCP1302+HGP0904Placebo

HCP1302+HGP0904Placebo for 12weeks

Group Type EXPERIMENTAL

HCP1302

Intervention Type DRUG

Placebo (for HGP0904)

Intervention Type DRUG

HCP1302Placebo+HGP0904

HCP1302Placebo+HGP0904 for 12weeks

Group Type ACTIVE_COMPARATOR

HGP0904

Intervention Type DRUG

Placebo (for HCP1302)

Intervention Type DRUG

Interventions

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HCP1302

Intervention Type DRUG

HGP0904

Intervention Type DRUG

Placebo (for HCP1302)

Intervention Type DRUG

Placebo (for HGP0904)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HM-TARO-301

Identifier Type: -

Identifier Source: org_study_id