Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01756430
First received: December 20, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension


Condition Intervention Phase
Hypertension
Drug: Carvedilol SR 32mg, QD
Drug: Carvedilol SR 64mg, QD
Drug: Carvedilol IR 25mg, QD
Drug: Carvedilol IR 25mg, BID
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: After 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Sitting systolic Blood Pressure (MSSBP) [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Control Rate [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Sitting DBP<90mmHg, Sitting SBP<140mmHg

  • Response Rate [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg


Enrollment: 238
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carvedilol SR 32mg, 64mg
•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.
Drug: 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.
Other Name: Dilatrend SR
Drug: 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.
Other Name: Dilatrend SR
Active Comparator: Carvedilol IR 25mg
•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.
Drug: 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.
Other Name: Dilatrend IR
Drug: Carvedilol IR 25mg, BID
  • Carvedilol IR 25mg BID for 4 weeks
  • With the others investigation product placebo 2 capsules QD for 4 weeks.
Other Name: Dilatrend IR

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756430

Locations
Korea, Republic of
The Hanyang Universitiy Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Soon Kill Kim The Hanyang Universitiy Guri Hospital
Principal Investigator: Sang-Hyun Ihm The Catholic University of Korea
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 NHIC 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 Soon Chun Hyang University Hospital
Principal Investigator: Young Jin Choi Sejong General Hospital
Principal Investigator: Hyuck Moon Kwon Gangnam Severance Hospital
Principal Investigator: Geu Ru Hong Yonsei University 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
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01756430     History of Changes
Other Study ID Numbers: 125HT12001
Study First Received: December 20, 2012
Last Updated: January 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Carvedilol SR
Carvedilol IR
Hypertension
Essential Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on August 28, 2014