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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03063697

Collaborator

(none)

20,000

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension Chronic Stable Angina Congestive Heart Failure

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
patients who check the safety data after taking Dilatrend SR

Outcome Measures

Primary Outcome Measures

The incidence and severity of adverse events and adverse drug reactions at 24 weeks [for 24 weeks]
The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks [for 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy or lactation
Known hypersensitivity to Carvedilol
Cardiogenic shock
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
Cor pulmonale
IDDM with ketoacidosis, metabolic acidosis
has severe heart disease(Heart failure NYHA functional class 4)
Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease
Secondary hypertension
Prinzmetal's angina
Acute pulmonary embolism
Pheochromocytoma
Take MAO lnhibitor(except for MAO-B)
Hypotension ( SBP 90mmHg or less)
Severe hepatic dysfunction
Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
Has edema glottitis
Has heart attack with complication
Fluid retention or overload to required intravenous inotropes
Allergic rhinitis