Efficacy and Safety of TELMINUVO to Stage 2 Hypertension
NCT ID: NCT01983735
Last Updated: 2013-11-14
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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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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Detailed Description
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* This study is consist of placebo run-in period(2 weeks\_single blind) and treatment period(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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TELMINUVO Tab. (80/2.5mg, 80/5mg)
TELMINUVO Tab. (80/2.5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.
* With the others investigation product placebo 1 tab QD 2 weeks.
TELMINUVO Tab. (80/5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.
* With the others investigation product placebo 1 tab QD 6 weeks.
S-Amlodipine 2.5, 5mg
S-amlodipine 2.5mg
* S-amlodipine 2.5mg QD 2 weeks
* With the others investigation product placebo 1 tab QD 2 weeks.
S-amlodipine 5mg
* S-amlodipine 5mg QD 6weeks
* With the others investigation product placebo 1 tab QD 6 weeks.
Interventions
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TELMINUVO Tab. (80/2.5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.
* With the others investigation product placebo 1 tab QD 2 weeks.
TELMINUVO Tab. (80/5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.
* With the others investigation product placebo 1 tab QD 6 weeks.
S-amlodipine 2.5mg
* S-amlodipine 2.5mg QD 2 weeks
* With the others investigation product placebo 1 tab QD 2 weeks.
S-amlodipine 5mg
* S-amlodipine 5mg QD 6weeks
* With the others investigation product placebo 1 tab QD 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at the screening visit
* antihypertensive drugs not taking: 160mmHg ≤ sitSBP \< 200mmHg
* antihypertensive drugs taking: 140mmHg ≤ sitSBP \< 180mmHg
* at the randomization visit(160mmHg ≤ sitSBP \< 200mmHg)
* willing and able to provide written informed consent
Exclusion Criteria
* 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 diseases status 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:
* hepatic dysfunction(AST/ALT \> UNL X 3)
* renal dysfunction(serum creatinine \> UNL X 1.5)
* hypopotassemia(K \< 3.0mmol/L) or hyperpotassemia (K\>5.5 mmol/L)
* 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 screening
* 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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The catholic university of Korea Seoul St. Mary's hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Ho-Joong Yoon, Ph.D
Role: primary
Other Identifiers
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130HT13015
Identifier Type: -
Identifier Source: org_study_id