Hypertension
Conditions
Keywords
Carvedilol SR, Carvedilol IR, Hypertension, Essential Hypertension
Brief summary
The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension
Detailed description
* In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks. * This study is consist of placebo run-in period(2\ 4 weeks\_single blind) and treatment period(8 weeks\_double blind).
Interventions
DRUGCarvedilol 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.
DRUGCarvedilol 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.
DRUGCarvedilol 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.
DRUGCarvedilol IR 25mg, BID
* Carvedilol IR 25mg BID for 4 weeks * With the others investigation product placebo 2 capsules QD for 4 weeks.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * 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
1. At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Sitting Diastolic Blood Pressure (MSDBP) | After 4 and 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 4 weeks and 8 weeks of treatment | — |
| Control Rate | After 8 weeks of treatment | Sitting DBP\<90mmHg, Sitting SBP\<140mmHg |
| Response Rate | After 8 weeks of treatment | Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg |
Countries
South Korea
Outcome results
None listed