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

PHASE3CompletedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

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."

Trial Locations (39)

425-707

Korea University Ansan Hospital, Ansan

431-796

Hallym University Medical Center, Anyang

420-767

Soonchunhyang University Hospital, Bucheon-si

602-715

Dong-A University Hospital, Busan

602-739

Pusan National University Hospital, Busan

607-711

Daedong Hospital, Busan

612-896

Inje University Haeundae Paik Hospital, Busan

614-735

Inje University Busan Paik Hospital, Busan

361-711,

Chungbuk National University Hospital, Cheongju-si

560-750

Presbyterian Medical Center, Cheonju

561-712

Chonbuk National University Hospital, Cheonju

700-712

Keimyung University Dongsan Medical Center, Daegu

705-718

Daegu Catholic University Medical Center, Daegu

301-721

Chungnam National University Hospital, Daejeon

302-718

Konyang University Hospital, Daejeon

410-719

Health Insurance Service Ilsan Hospital, Goyang

471-701

Hanyang University Guri Hospital, Guri-si

501-757

Chonnam National University Hospital, Gwangju

405-835

Gachon University Gil Medical Center, Incheon

463-707

Seoul National University Bundang Hospital, Seongnam

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital, Seoul

130-702

Kyung Hee University Medical Center, Seoul

134-727

Kyunghee University Hospital at Gandong, Seoul

134-791

Seoul Veterans Hospital, Seoul

135-710

Sanmsung Medical Center, Seoul

135-720

Gangnam Severance Hospital, Seoul

136-705

Korea University Anam Hospital, Seoul

137-701

Seoul St. Mary's Hospital of the Catholic University of Korea, Seoul

138-736

Asan Medical Center, Seoul

139-711

Eulji General Hospital, Seoul

143-729

Konkuk University Medical Center, Seoul

150-713

Yeouido St. Mary's Hospital of the Catholic University of Korea, Seoul

152-840

Korea University Guro Hospital, Seoul

156-755

Chung-Ang University Hospital, Seoul

540-719

St. Carollo Hospital, Suncheon

443-380

Ajou University Hospital, Suwon

682-714

Ulsan University hospital, Ulsan

220-701

Wonju Severance Christian Hospital, Wŏnju

All Listed Sponsors
lead

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

INDUSTRY

NCT01838850 - 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 | Biotech Hunter | Biotech Hunter