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
- Conditions
- Essential Hypertension
- Interventions
- Drug: CS8635 20/5/12.5mg and placebo
- Registration Number
- NCT01838850
- Lead Sponsor
- Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
- Brief 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).
- Detailed Description
Please refer to arms, outcome measures and eligibility criteria for details.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
Not provided
- msDBP ≥ 115mmHg or msSBP ≥ 200 mmHg measured at screening and randomization
- Patients with mini-max blood pressure difference of SeSBP ≥ 20 mmHg or SeDBP ≥ 10 mmHg in the chosen arm at screening
- Patients with blood pressure difference of SeSBP ≥ 20 mmHg and SeDBP ≥ 10 mmHg in both arms at screening
- Patients with hypersensitivity to the investigational product or any of its components
- Patients with medical history or hypersensitivity to sulfonamide, dihydropyridine, or thiazide diuretics
- History of secondary hypertension or history of any of the diseases suspected of secondary hypertension
- Symptomatic orthostatic hypotension
- Uncontrolled diabetes mellitus
- Severe heart disease, or ischemic heart disease, peripheral vascular disease
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant
- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis on aortic valve or mitral valve.
- Severe cerebrovascular disorder
- Known moderate or malignant retinopathy
- Consumption disease , autoimmune disease, or connective tissue disease
- Patients requiring chronic anti-inflammatory treatment
- Anuria or severe renal failure
- Severe hepatic failure, AST or ALT > 3 times the upper limit of normal, biliary obstruction, biliary cirrhosis, or cholestasis
- Patients who have been treated for hyponatremia, hypokalemia, hyperkalemia, hypercalcemia, or symptomatic hyperuricemia
- Addison's disease
- Glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency
- Gastrointestinal tract disease or surgical operation that may affect absorption, distribution, metabolism, and excretion of drugs, presence of active gastritis or gastrointestinal/rectal bleeding considered clinical significant by the investigator, active inflammatory bowel syndrome within the last 12 months, etc
- Patients with history of or suspected of drug or alcohol abuse
- Pregnant or lactating women, or women of childbearing potential who do not agree to use appropriate contraceptive methods such as progestin hormone therapy (Oral, implant), intrauterine device, barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide), male sterilisation or true abstinence
- Patients who participated in other clinical study within 1 month prior to screening
- Patients considered to be incapable of complying with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olmetec® Plus 20/12.5mg and placebo Olmetec® Plus 20/12.5mg and placebo Participants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this dual fixed dose combination therapy (Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5mg) + Placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5 mg). CS8635 20/5/12.5mg and placebo CS8635 20/5/12.5mg and placebo Participants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this triple fixed dose combination therapy (CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5mg) + placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 40/5/12.5mg (OM/AML/HCTZ 40/5/12.5 mg).
- Primary Outcome Measures
Name Time Method The changes of seated diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg from baseline to week 8
- Secondary Outcome Measures
Name Time Method Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg at Week 4, and Week 8 The changes of mean seated systolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg from baseline to Week 8 The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg from baseline to week 4 Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg At week 16 The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg from Week 8 to Week 16
Trial Locations
- Locations (39)
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Daedong Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Presbyterian Medical Center
🇰🇷Cheonju, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Kyunghee University Hospital at Gandong
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Health Insurance Service Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital of the Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Sanmsung Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital of the Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Ulsan University hospital
🇰🇷Ulsan, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of