Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy

Summary

CS-8635 combines three widely prescribed antihypertensive medications, olmesartan medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635 compared with dual therapy in Korean patients with hypertension not controlled with dual fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg).

Conditions

• Essential Hypertension

Interventions

DRUG

CS8635 20/5/12.5mg and placebo

Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day. Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine (AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, oral placebo tablet. All tablets are given once a day. Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 40-5-12.5mg, given once a day.

DRUG

Olmetec® Plus 20/12.5mg and placebo

Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day. Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, oral placebo tablet. All tablets are given once a day. Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, given once a day.

Sponsors & Collaborators

• Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

  lead INDUSTRY

Principal Investigators

• Chang-Wook Nam · Keimyung University Dongsan Medical Center

• Cheol-Ho Kim · Seoul National University Bundang Hospital

• Sang-Hong Baek · Seoul St. Mary's Hospital of the Catholic University of Korea

• Woo-Baek Chung · Yeouido St. Mary's Hospital of the Catholic University of Korea

• Woo-Shik Kim · Kyunghee University Medical Center

• Tae-Hoon Ahn · Gachon University Gil Medical Center

• Jang-Hyun Cho · St. Carollo Hospital

• Byung-Hee Oh · Seoul National Univerisity Hospital

• Hweung-Kon Hwang · Konkuk University Medical Center

• Chang-Gyu Park · Korea University Guro Hospital

• Eun-Seok Shin · Ulsan University Hospital

• Dong-Ju Choi · Seoul National University Bundang Hospital

• Joon-Han Shin · Ajou University School of Medicine

• Myung-Ho Jeong · Chonnam National University Hospital

• Jin-Ok Jeong · Chungnam National University Hospital

• Chong-Jin Kim · Kyunghee University Hospital at Gandong

• Jang-Ho Bae · Konyang University Hospital

• Seung-Hwan Lee · Wonju Severance Christian Hospital

• Se-Joong Rim · Gangnam Severance Hospital

• Jay-Young Rhew · Presbyterian medical center

• Doo-Il Kim · Inje University

• Dae-Kyeong Kim · Inje University

• Soon-Kil Kim · Hanyang University

• Hye-Sun Seo · Soonchunhyang University Hospital

• Duk-Hyun Kang · Asan Medical Center

• Young-Dae Kim · Dong-A University Hospital

• Dong-Woon Kim · Chungbuk National University Hospital

• Taek-Jong Hong · Pusan National University Hospital

• Jong-Won Ha · Severance Hospital

• Woo-Jung Park · Hallym University Medical Center

• Tae Ho Kim · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

• Kee-Sik Kim · Daegu Catholic University Medical Center

• Seung-Woo Park · Sanmsung Medical Center

• Wan-Joo Shim · Korea University Anam Hospital

• Joo-Young Yang · Health Insurance Service Ilsan Hospital

• Jae-Woong Choi · Eulji General Hospital

• Sun-Hwa Lee · Chonbuk National University Hospital

• Jeong-Cheon Ahn · Korea University

• Keun Lee · Seoul Veterans Hospital

• Byung-Soo Kim · Daedong Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• South Korea

Study Locations