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

January 13, 2014 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • The Hanyang Universitiy Guri Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Dilatrend IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: After 4 and 8 weeks of treatment
After 4 and 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Sitting systolic Blood Pressure (MSSBP)
Time Frame: After 4 weeks and 8 weeks of treatment
After 4 weeks and 8 weeks of treatment
Control Rate
Time Frame: After 8 weeks of treatment
Sitting DBP<90mmHg, Sitting SBP<140mmHg
After 8 weeks of treatment
Response Rate
Time Frame: After 8 weeks of treatment
Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg
After 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 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: Min Su Hyon, Soon Chun Hyang University Hospital
  • Principal Investigator: Young Jin Choi, Sejong General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (ESTIMATE)

December 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125HT12001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Carvedilol SR 32mg, QD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe