Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Carvedilol SR 32mg, QD (Drug); Carvedilol SR 64mg, QD (Drug); Carvedilol IR 25mg, QD (Drug); Carvedilol IR 25mg, BID (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s): Soon Kill Kim, Principal Investigator, Affiliation: The Hanyang Universitiy Guri Hospital Sang-Hyun Ihm, Principal Investigator, Affiliation: The Catholic University of Korea Sang Hong Haek, Principal Investigator, Affiliation: The Catholic University of Korea, Seoul St. Vincent's Hospital Jin-Bae Kim, Principal Investigator, Affiliation: Kyunghee University Medical Center Dong Woon Jeon, Principal Investigator, Affiliation: NHIC Ilsan hospital Chang-Wook Nam, Principal Investigator, Affiliation: Keimyung University, Donsan Hospital Dong-Ju Choi, Principal Investigator, Affiliation: Seoul National University Bundang Hospital Min Su Hyon, Principal Investigator, Affiliation: Soon Chun Hyang University Hospital Young Jin Choi, Principal Investigator, Affiliation: Sejong General Hospital Hyuck Moon Kwon, Principal Investigator, Affiliation: Gangnam Severance Hospital Geu Ru Hong, Principal Investigator, Affiliation: Yonsei University Severance Hospital Byung-Su Yoo, Principal Investigator, Affiliation: Wonju Severance Christian Hospital Ji-Hyun Lim, Principal Investigator, Affiliation: Jesus hospital Young Keun Ahn, Principal Investigator, Affiliation: Chonnam National University Hospital Jin Ho Shin, Principal Investigator, Affiliation: Hanyang University Seoul Hospital
Summary
The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus
Carvedilol IR in Patients With Essential Hypertension
Clinical Details
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Sitting Diastolic Blood Pressure (MSDBP)
Secondary outcome: Mean Sitting systolic Blood Pressure (MSSBP)Control Rate Response Rate
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
The Hanyang Universitiy Guri Hospital, Guri-si, Gyeonggi-do 471-701, Korea, Republic of
Additional Information
Starting date: December 2012
Last updated: January 13, 2014
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