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
187 participants
INTERVENTIONAL
2011-08-31
2012-09-30
Brief Summary
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Detailed Description
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* Included S-Amlodipine run-in period(during 4 weeks\_single blind) and Treatment period(during 8 weeks\_double blind).
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 2.5/40mg
CKD-828 2.5/40mg
CKD-828 2.5/40mg
fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg
CKD-828 2.5/80mg
CKD-828 2.5/80mg
CKD-828 2.5/80mg
Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
S-Amlodipine 2.5mg
S-Amlodipine 2.5mg
S-Amlodipine 2.5mg
S-Amlodipine 2.5mg monotherapy
Interventions
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CKD-828 2.5/40mg
fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg
CKD-828 2.5/80mg
Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
S-Amlodipine 2.5mg
S-Amlodipine 2.5mg monotherapy
Other Intervention Names
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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 amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
* failure to respond to four weeks treatment with S-Amlodipine 2.5mg(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%
* 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 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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Principal Investigators
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Ho-Joong Yoon, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's hospital, The catholic university of Korea
Locations
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Seoul St. Mary's hospital, The catholic university of Korea
Seoul, , South Korea
Countries
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Other Identifiers
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130HT11A
Identifier Type: -
Identifier Source: org_study_id