Essential HypertensionDELIGHTNCT03063697
Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure
An observational study of Essential Hypertension and Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Chronic Stable Angina, Congestive Heart Failure
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: in Korean 20,000 Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
- Has edema glottitis
- Has heart attack with complication
- Fluid retention or overload to required intravenous inotropes
- Allergic rhinitis
About this study
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
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.
- Keywords
- Carvedilol SR Cap, Essential hypertension, Chronic stable angina, Congestive heart failure
- Medical subject headings
- Essential Hypertension, Angina, Stable, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who check the safety data after taking Dilatrend SR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events and adverse drug reactions at 24 weeks
Measured: for 24 weeks
The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks
Measured: for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startNov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063697
- Sponsor's protocol ID
- 425HT15021
- Acronym
- DELIGHT
- Status last verified
- Feb 2017
- First submitted
- 23 May 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03063697
- Acronym / sponsor ID
- DELIGHT / 425HT15021
- Keywords
- Carvedilol SR Cap, Essential hypertension, Chronic stable angina, Congestive heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who check the safety data after taking Dilatrend SR | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- in Korean 20,000 Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence and severity of adverse events and adverse drug reactions at 24 weeks
Time frame: for 24 weeks
The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks
Time frame: for 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension and Chronic Stable Angina, run by Chong Kun Dang Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events and adverse drug reactions at 24 weeks (time frame: for 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.