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The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-828 2.5/40, 2.5/80, 5/80mg | Experimental |
| |
| S-Amlodipine 2.5, 5mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 2.5/40mg | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 10 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 2 weeks, 4 weeks and 6 weeks of treatment | |
| Mean Sitting diastolic Blood Pressure (MSDBP) | After 2weeks, 4weeks, 6weeks and 10 weeks of treatment |
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Inclusion Criteria:
age 18 years or older
at the screening visit
at the randomization visit(160mmHg ≤ sitSBP < 200mmHg)
willing and able to provide written informed consent
Exclusion Criteria:
mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
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), ischaemic heart diseasesstatus need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
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
defined by the following laboratory parameters:
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 4weeks 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
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| Name | Affiliation | Role |
|---|---|---|
| Tae-hoon An, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
| Eun-joo Jo, Ph.D | The Catholic university of Korea St. Paul's Hospitial | Principal Investigator |
| Jong-jin Kim, Ph.D | Kyung Hee university Hosipital at Gangdong | Principal Investigator |
| Jang-ho Bae, Ph.D | Konyang University Hosipital | Principal Investigator |
| Chang-kyu Park, Ph.D | Korea University Guro Hospital | Principal Investigator |
| Young-dae Kim, Ph.D | Dong-A University | Principal Investigator |
| Chul-ho Kim, Ph.D | Seoul National University Bundang Hospital | Study Chair |
| Sae-Joong Lim, Ph.D | Gangnam Severance Hospital | Principal Investigator |
| Uk-Bum Phyun, Ph.D | Ewha Women University Mokdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university Bundang Hospital | Bundang-gu | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542574 | levamlodipine |
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| CKD-828 5/40mg | Drug |
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| CKD-828 5/80mg | Drug |
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| S-amlodipine 2.5mg | Drug |
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| S-amlodipine 5mg | Drug |
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| Control Rate | Sitting SBP<140mmHg, Sitting DBP<90mmHg | After 10 weeks of treatment |
| Response Rate | Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg | After 10 weeks of treatment |
| Gyu-Rok Han, Ph.D |
| Kangdong Sacred Heart Hospital |
| Principal Investigator |
| Sang Hyun Kim, Ph.D | Seoul National University Boramae Hospital | Principal Investigator |