CKD-828 Primary Hypertension Trial(Dose-selection)
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01128322
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 430
- age 18 years or older
- stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
- ability to provide written informed consent
- severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
- known severe or malignant retinopathy
- hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5
- acute or chronic inflammatory status need to treatment
- need to additional antihypertensive drugs during the study
- need to concomitant medications known to affect blood pressure during the study
- history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
- known hypersensitivity related to either study drug
- history of drug or alcohol dependency
- any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
- cannot swallow investigational products
- administration of other study drugs within 4 weeks prior to randomization
- premenopausal women(last menstration < 1year) not using adequte contraception, pregnant or breast-feeding
- history of malignancy including leukemia and lymphoma within the past 5 years
- in investigator's judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo - S-Amlodipine 2.5mg + Telmisartan 40mg S-Amlodipine, Telmisartan - S-Amlodipine 2.5mg + Telmisartan 80mg S-Amlodipine, Telmisartan - S-Amlodipine 5mg + Telmisartan 40mg S-Amlodipine, Telmisartan - S-Amlodipine 5mg + Telmisartan 80mg S-Amlodipine, Telmisartan - S-Amlodipine 2.5mg S-Amlodipine - S-Amlodipine 5mg S-Amlodipine - Telmisartan 40mg Telmisartan - Telmisartan 80mg Telmisartan -
- Primary Outcome Measures
Name Time Method Mean Sitting Diastolic Blood Pressure(MSDBP) After 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Mean Sitting Diastolic Blood Pressure(MSDBP) After 4 weeks of treatment Mean Sitting Systolic Blood Pressure(MSSBP) After 4 weeks and 8 weeks of treatment Response rate After 4 weeks and 8 weeks of treatment Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg
Control rate After 4 weeks and 8 weeks of treatment Reduction SBP \< 140mmHg, DBP \< 90mmHg
Trial Locations
- Locations (26)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
DonGuk University International Hospital
🇰🇷Goyang, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Inchon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Soonchunhyang University Hospital in Bucheon
🇰🇷Bucheon, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Chungbuk National Uiversity Hospital
🇰🇷Cheongju, Korea, Republic of
Kandong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
St. Paul's Hospital, The catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Uijeongbu St. Mary's Hospital, The catholic University of Korea
🇰🇷Uijeongbu, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Ewha Womans University Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The catholic University of Korea
🇰🇷Seoul, Korea, Republic of