Efficacy and Safety of CKD-828 to Stage 2 Hypertension

Summary

The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Conditions

• Hypertension

Interventions

DRUG

CKD-828 2.5/40mg

* Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.

DRUG

CKD-828 5/40mg

* Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.

DRUG

CKD-828 5/80mg

* Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks. * With the others investigation product placebo 4 tabs QD 6 weeks.

DRUG

S-amlodipine 2.5mg

* S-amlodipine 2.5mg QD 4 weeks * With the others investigation product placebo 4 tabs QD 4 weeks.

DRUG

S-amlodipine 5mg

* S-amlodipine 2.5mg QD 6weeks * With the others investigation product placebo 4 tabs QD 6 weeks.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical

  lead INDUSTRY

Principal Investigators

• Tae-hoon An, Ph.D · Gachon University Gil Medical Center

• Eun-joo Jo, Ph.D · The Catholic university of Korea St. Paul's Hospitial

• Jong-jin Kim, Ph.D · Kyung Hee university Hosipital at Gangdong

• Jang-ho Bae, Ph.D · Konyang University Hosipital

• Chang-kyu Park, Ph.D · Korea University Guro Hospital

• Young-dae Kim, Ph.D · Dong-A University

• Chul-ho Kim, Ph.D · Seoul National University Bundang Hospital

• Sae-Joong Lim, Ph.D · Gangnam Severance Hospital

• Uk-Bum Phyun, Ph.D · Ewha Women University Mokdong Hospital

• Gyu-Rok Han, Ph.D · Kangdong Sacred Heart Hospital

• Sang Hyun Kim, Ph.D · Seoul National University Boramae Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• South Korea