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

Congestive Heart Failure Clinical Trial

— DELIGHT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03063697
• Other study ID #: 425HT15021
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 23, 2016
• Last updated: February 21, 2017
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina
• Congestive Heart Failure
• Essential Hypertension
• Heart Failure
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of adverse events and adverse drug reactions at 24 weeks		for 24 weeks
Primary	The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks		for 24 weeks