A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension

Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

Conditions

• Hypertension

Interventions

DRUG

Fimasartan , Amlodipine, Placebo

Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination

Sponsors & Collaborators

• Gachon University Gil Medical Center

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Daegu Catholic University Medical Center

  collaborator OTHER

• Wonkwang University Hospital

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• DongGuk University

  collaborator OTHER

• Yeungnam University Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Cheil General Hospital and Women's Healthcare Center

  collaborator OTHER

• Chungnam National University

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Busan National University Yangsan Hospital

  collaborator UNKNOWN

• Soon Chun Hyang University

  collaborator OTHER

• Catholic University of Korea Saint Paul's Hospital

  collaborator OTHER

• Hallym University Kangnam Sacred Heart Hospital

  collaborator OTHER

• Jeju National University Hospital

  collaborator OTHER

• Hanyang University Seoul Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Boryung Pharmaceutical Co., Ltd

  lead INDUSTRY

Principal Investigators

• Young Kwan Jeon, Medical Director · Boryung Pharmaceutical Co., Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2013-10-31

Completion

2013-11-30

Countries

• South Korea

Study Locations