NCT03063697

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

5.1 years

First QC Date

May 23, 2016

Last Update Submit

February 21, 2017

Conditions

Essential HypertensionChronic Stable AnginaCongestive Heart Failure

Keywords

Carvedilol SR CapEssential hypertensionChronic stable anginaCongestive heart failure

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

patients who check the safety data after taking Dilatrend SR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

in Korean 20,000 Patients with Essential hypertension, Chronic stable angina and Congestive heart failure

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential HypertensionAngina, StableHeart Failure

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesAngina PectorisMyocardial IschemiaHeart DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

February 24, 2017

Study Start

November 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share