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

• Conditions: Essential Hypertension; Chronic Stable Angina; Congestive Heart Failure

• Registration Number: NCT03063697
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-05-23
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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