DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017