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

NCT ID: NCT03063697

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Essential Hypertension Chronic Stable Angina Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who check the safety data after taking Dilatrend SR

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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425HT15021

Identifier Type: -

Identifier Source: org_study_id

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