Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
NCT ID: NCT01756430
Last Updated: 2014-01-14
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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COMPLETED
PHASE3
238 participants
INTERVENTIONAL
2012-12-31
2013-09-30
Brief Summary
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Detailed Description
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* This study is consist of placebo run-in period(2\~4 weeks\_single blind) and treatment period(8 weeks\_double blind).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Carvedilol SR 32mg, 64mg
•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.
Carvedilol SR 32mg, QD
* Carvedilol SR 32mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol SR 64mg, QD
* Carvedilol SR 64mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol IR 25mg
•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.
Carvedilol IR 25mg, QD
* Carvedilol IR 25mg QD for 4 weeks
* With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.
Carvedilol IR 25mg, BID
* Carvedilol IR 25mg BID for 4 weeks
* With the others investigation product placebo 2 capsules QD for 4 weeks.
Interventions
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Carvedilol SR 32mg, QD
* Carvedilol SR 32mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol SR 64mg, QD
* Carvedilol SR 64mg QD for 4 weeks
* With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol IR 25mg, QD
* Carvedilol IR 25mg QD for 4 weeks
* With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.
Carvedilol IR 25mg, BID
* Carvedilol IR 25mg BID for 4 weeks
* With the others investigation product placebo 2 capsules QD for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at the screening visit(visit 1)
* antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP \< 180mmHg
* antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP \< 180mmHg
* at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP \< 180mmHg
* willing and able to provide written informed consent
Exclusion Criteria
2. known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
3. Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c \> 9%)
4. Corresponding to the following
* has severe heart disease(Heart failure NYHA functional class 3, 4)
* ischaemic heart diseases within 6 months (unstable angina or myocardial infarction)
* myocardiopathy
* Cor pulmonale
* aortic stenosis , aortic valvular stenosis , mitral stenosis
* abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse \<50beats / min)
* has heart attack with complication.
5. has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
6. has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
7. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
8. Fluid retention or overload to required intravenous inotropes.
9. known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
10. defined by the following laboratory parameters:
* hepatic dysfunction(AST/ALT ≥ UNL X 3)
* renal dysfunction(serum creatinine ≥ UNL X 2)
11. 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)
12. history of drug or alcohol dependency within 6 months
13. premenopausal women(last menstruation \< 12 months) not using adequate contraception, pregnant or breast-feeding
14. chronic inflammatory status need to treatment
15. known hypersensitivity related to carvedilol
16. history of malignancy including leukemia and lymphoma within the past 5 years
17. administration of other study drugs within 28 days prior to the first IP administration
18. 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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Soon Kill Kim
Role: PRINCIPAL_INVESTIGATOR
The Hanyang Universitiy Guri Hospital
Sang-Hyun Ihm
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea Bucheon St.Mary's Hospital
Sang Hong Haek
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea, Seoul St. Vincent's Hospital
Jin-Bae Kim
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Dong Woon Jeon
Role: PRINCIPAL_INVESTIGATOR
National Health Insurance Service Ilsan Hospital
Chang-Wook Nam
Role: PRINCIPAL_INVESTIGATOR
Keimyung University, Donsan Hospital
Dong-Ju Choi
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Min Su Hyon
Role: PRINCIPAL_INVESTIGATOR
Soon Chun Hyang University Hospital
Young Jin Choi
Role: PRINCIPAL_INVESTIGATOR
Sejong General Hospital
Hyuck Moon Kwon
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Geu Ru Hong
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Byung-Su Yoo
Role: PRINCIPAL_INVESTIGATOR
Wonju Severance Christian Hospital
Ji-Hyun Lim
Role: PRINCIPAL_INVESTIGATOR
Jesus hospital
Young Keun Ahn
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Jin Ho Shin
Role: PRINCIPAL_INVESTIGATOR
Hanyang University Seoul Hospital
Locations
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The Hanyang Universitiy Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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125HT12001
Identifier Type: -
Identifier Source: org_study_id
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