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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03063697

Acronym

DELIGHT

Enrollment

20000

Registered

2017-02-24

Start date

2015-11-30

Completion date

2020-12-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stable Angina, Congestive Heart Failure, Essential Hypertension

Keywords

Carvedilol SR Cap, Essential hypertension, Chronic stable angina, Congestive heart failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results