Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2011-08-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CKD-828 40/2.5mg
CKD-828 40/2.5mg
Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
CKD-828 40/5mg
CKD-828 40/5mg
Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg
Telmisartan 80mg
Telmisartan 80mg
Telmisartan 80mg monotherapy
Interventions
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CKD-828 40/2.5mg
Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
CKD-828 40/5mg
Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg
Telmisartan 80mg
Telmisartan 80mg monotherapy
Eligibility Criteria
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Inclusion Criteria
* diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(DBP)\>= 90mmHg if on existing antihypertensive treatment of seated DBP \>= 100mmHg if treatment naive)
* failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated DBP \>= 90mmHg)
* willing and able to provide written informed consent
Exclusion Criteria
* 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 Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
* nown 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 within 6 months
* 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, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding
* administration of other study drugs within 30 days prior to randomization
* premenopausal women(last menstruation \< 1year) not using adequate contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment
18 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Kandong Sacred Heart Hospital
Anyang, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
DonGuk University Ilsan Hospital
Goyang, , South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang, , South Korea
Gachon University Gil Medical Center
Inchon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Bundang Cha Medical Center
Seoul, , South Korea
Ewha Womans University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Inje University Ilsan Paik Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soon Chun Hyang University Hospital
Seoul, , South Korea
St. Paul's Hospital, The catholic University of Korea
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
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Other Identifiers
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130HT11B
Identifier Type: -
Identifier Source: org_study_id