Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure (DELIGHT)

February 21, 2017 updated by: Chong Kun Dang Pharmaceutical

Prospective, Multi-center, Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure

The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20000

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

in Korean 20,000 Patients with Essential hypertension, Chronic stable angina and Congestive heart failure

Description

Inclusion Criteria:

  1. Age 19 years or older Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
  2. Possible to take Dilatrend SR on the label
  3. not taking Caverdilol for 6 month from Agreement date
  4. Agreement with written informed consent

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Known hypersensitivity to Carvedilol
  3. Cardiogenic shock
  4. Abnormality of the conduction system as Severe bradycardia(In particular, pulse <50beats / min), 2nd degree AV block, Complete AV block, Sinus Block, Sick Sinus Syndrome
  5. Cor pulmonale
  6. IDDM with ketoacidosis, metabolic acidosis
  7. has severe heart disease(Heart failure NYHA functional class 4)
  8. Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease
  9. Secondary hypertension
  10. Prinzmetal's angina
  11. Acute pulmonary embolism
  12. Pheochromocytoma
  13. Take MAO lnhibitor(except for MAO-B)
  14. Hypotension ( SBP 90mmHg or less)
  15. Severe hepatic dysfunction
  16. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
  17. Has edema glottitis
  18. Has heart attack with complication
  19. Fluid retention or overload to required intravenous inotropes
  20. Allergic rhinitis

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

Cohorts and Interventions

Group / Cohort
patients who check the safety data after taking Dilatrend SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of adverse events and adverse drug reactions at 24 weeks
Time Frame: for 24 weeks
for 24 weeks
The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks
Time Frame: for 24 weeks
for 24 weeks

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

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

November 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 425HT15021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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