HypertensionPhase 3NCT01756430
Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
A Phase 3 study testing Carvedilol SR 32mg, QD, Carvedilol SR 64mg, QD and Carvedilol IR 25mg, QD in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Carvedilol SR 32mg, QD, Carvedilol SR 64mg, QD and Carvedilol IR 25mg, QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- at the screening visit(visit 1)
- antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP < 180mmHg
- at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- willing and able to provide written informed consent
Who cannot join
- At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%)
- Corresponding to the following
- has severe heart disease(Heart failure NYHA functional class 3, 4)
- ischaemic heart diseases within 6 months (unstable angina or myocardial infarction)
Show all 27Show fewer
- myocardiopathy
- Cor pulmonale
- aortic stenosis , aortic valvular stenosis , mitral stenosis
- abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse <50beats / min)
- has heart attack with complication.
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
- Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
- Fluid retention or overload to required intravenous inotropes.
- known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
- defined by the following laboratory parameters:
- hepatic dysfunction(AST/ALT ≥ UNL X 3)
- renal dysfunction(serum creatinine ≥ UNL X 2)
- any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
- history of drug or alcohol dependency within 6 months
- premenopausal women(last menstruation < 12 months) not using adequate contraception, pregnant or breast-feeding
- chronic inflammatory status need to treatment
- known hypersensitivity related to carvedilol
- history of malignancy including leukemia and lymphoma within the past 5 years
- administration of other study drugs within 28 days prior to the first IP administration
- in investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Hanyang Universitiy Guri Hospital
Guri-si, Gyeonggi-do, 471-701
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension
Read the detailed description
- In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks.
- This study is consist of placebo run-in period(2~4 weeks_single blind) and treatment period(8 weeks_double blind).
- Conditions
- Hypertension
- Being tested
- Carvedilol SR 32mg, QD, Carvedilol SR 64mg, QD, Carvedilol IR 25mg, QD, Carvedilol IR 25mg, BID
- Keywords
- Carvedilol SR, Carvedilol IR, Hypertension, Essential Hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol SR 32mg, QDDrug
Also called Dilatrend SR
- Carvedilol SR 32mg QD for 4 weeks
- With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol SR 64mg, QDDrug
Also called Dilatrend SR
- Carvedilol SR 64mg QD for 4 weeks
- With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
Carvedilol IR 25mg, QDDrug
Also called Dilatrend IR
- Carvedilol IR 25mg QD for 4 weeks
- With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.
Carvedilol IR 25mg, BIDDrug
Also called Dilatrend IR
- Carvedilol IR 25mg BID for 4 weeks
- With the others investigation product placebo 2 capsules QD for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol SR 32mg, 64mg | Experimental | •Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks. Receives: Drug: Carvedilol SR 32mg, QD; Drug: Carvedilol SR 64mg, QD |
| Carvedilol IR 25mg | Active comparator | •Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks. Receives: Drug: Carvedilol IR 25mg, QD; Drug: Carvedilol IR 25mg, BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: After 4 and 8 weeks of treatment
Secondary outcomes (3)
Mean Sitting systolic Blood Pressure (MSSBP)
Measured: After 4 weeks and 8 weeks of treatment
Control Rate
Sitting DBP<90mmHg, Sitting SBP<140mmHg
Measured: After 8 weeks of treatment
Response Rate
Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg
Measured: After 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soon Kill Kim, Principal investigator, The Hanyang Universitiy Guri HospitalSang-Hyun Ihm, Principal investigator, The Catholic University of Korea Bucheon St.Mary's HospitalSang Hong Haek, Principal investigator, The Catholic University of Korea, Seoul St. Vincent's HospitalJin-Bae Kim, Principal investigator, Kyunghee University Medical CenterDong Woon Jeon, Principal investigator, National Health Insurance Service Ilsan HospitalChang-Wook Nam, Principal investigator, Keimyung University, Donsan HospitalDong-Ju Choi, Principal investigator, Seoul National University Bundang HospitalMin Su Hyon, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756430
- Sponsor's protocol ID
- 125HT12001
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01756430
- Acronym / sponsor ID
- 125HT12001
- Conditions
- Hypertension
- Keywords
- Carvedilol SR, Carvedilol IR, Hypertension, Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Dec 2012 (estimated)
- 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 aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension
Detailed description
- In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks.
- This study is consist of placebo run-in period(2~4 weeks_single blind) and treatment period(8 weeks_double blind).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol SR 32mg, 64mg | Experimental | Drug: Carvedilol SR 32mg, QD, Drug: Carvedilol SR 64mg, QD•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks. |
| Carvedilol IR 25mg | Active comparator | Drug: Carvedilol IR 25mg, QD, Drug: Carvedilol IR 25mg, BID•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- at the screening visit(visit 1)
- at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- willing and able to provide written informed consent
Key exclusion criteria (27 listed)
- At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%)
- Corresponding to the following
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol SR 32mg, QDAlso: Dilatrend SR* Carvedilol SR 32mg QD for 4 weeks * With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks. | Drug | Carvedilol SR 32mg, 64mg |
| Carvedilol SR 64mg, QDAlso: Dilatrend SR* Carvedilol SR 64mg QD for 4 weeks * With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks. | Drug | Carvedilol SR 32mg, 64mg |
| Carvedilol IR 25mg, QDAlso: Dilatrend IR* Carvedilol IR 25mg QD for 4 weeks * With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks. | Drug | Carvedilol IR 25mg |
| Carvedilol IR 25mg, BIDAlso: Dilatrend IR* Carvedilol IR 25mg BID for 4 weeks * With the others investigation product placebo 2 capsules QD for 4 weeks. | Drug | Carvedilol IR 25mg |
Primary outcome
Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: After 4 and 8 weeks of treatment
3 secondary outcomes
Mean Sitting systolic Blood Pressure (MSSBP)
Time frame: After 4 weeks and 8 weeks of treatment
Control Rate
Time frame: After 8 weeks of treatment
Response Rate
Time frame: After 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Soon Kill Kim principal investigator
The Hanyang Universitiy Guri Hospital
Sang-Hyun Ihm principal investigator
The Catholic University of Korea Bucheon St.Mary's Hospital
Sang Hong Haek principal investigator
The Catholic University of Korea, Seoul St. Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carvedilol SR 32mg, QD, Carvedilol SR 64mg, QD and Carvedilol IR 25mg, QD in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 6 inclusion and 27 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: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Sitting Diastolic Blood Pressure (MSDBP) (time frame: After 4 and 8 weeks of treatment). 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 14 Jan 2014.