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The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol SR 32mg, 64mg | Experimental | •Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks. |
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| Carvedilol IR 25mg | Active Comparator | •Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol SR 32mg, QD | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting Diastolic Blood Pressure (MSDBP) | After 4 and 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 4 weeks and 8 weeks of treatment | |
| Control Rate | Sitting DBP<90mmHg, Sitting SBP<140mmHg | After 8 weeks of treatment |
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Inclusion Criteria:
age 18 years or older
at the screening visit(visit 1)
at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
willing and able to provide written informed consent
Exclusion Criteria:
At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%)
Corresponding to the following
has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
Fluid retention or overload to required intravenous inotropes.
known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
defined by the following laboratory parameters:
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)
history of drug or alcohol dependency within 6 months
premenopausal women(last menstruation < 12 months) not using adequate contraception, pregnant or breast-feeding
chronic inflammatory status need to treatment
known hypersensitivity related to carvedilol
history of malignancy including leukemia and lymphoma within the past 5 years
administration of other study drugs within 28 days prior to the first IP administration
in investigator's judgment
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| Name | Affiliation | Role |
|---|---|---|
| Soon Kill Kim | The Hanyang Universitiy Guri Hospital | Principal Investigator |
| Sang-Hyun Ihm | The Catholic University of Korea Bucheon St.Mary's Hospital | Principal Investigator |
| Sang Hong Haek | The Catholic University of Korea, Seoul St. Vincent's Hospital | Principal Investigator |
| Jin-Bae Kim | Kyunghee University Medical Center | Principal Investigator |
| Dong Woon Jeon | National Health Insurance Service Ilsan Hospital | Principal Investigator |
| Chang-Wook Nam | Keimyung University, Donsan Hospital | Principal Investigator |
| Dong-Ju Choi | Seoul National University Bundang Hospital | Principal Investigator |
| Min Su Hyon | Soonchunhyang University Hospital | Principal Investigator |
| Young Jin Choi | Sejong General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hanyang Universitiy Guri Hospital | Guri-si | Gyeonggi-do | 471-701 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Carvedilol SR 64mg, QD | Drug |
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| Carvedilol IR 25mg, QD | Drug |
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| Carvedilol IR 25mg, BID | Drug |
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| Response Rate | Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg | After 8 weeks of treatment |
| Hyuck Moon Kwon | Gangnam Severance Hospital | Principal Investigator |
| Geu Ru Hong | Severance Hospital | Principal Investigator |
| Byung-Su Yoo | Wonju Severance Christian Hospital | Principal Investigator |
| Ji-Hyun Lim | Jesus hospital | Principal Investigator |
| Young Keun Ahn | Chonnam National University Hospital | Principal Investigator |
| Jin Ho Shin | Hanyang University Seoul Hospital | Principal Investigator |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |