HypertensionPhase 3NCT01501253
CKD-828 S-Amlodipine Non-Responder Trial
A Phase 3 study testing CKD-828 2.5/40mg, CKD-828 2.5/80mg and S-Amlodipine 2.5mg 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 two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-828 2.5/40mg, CKD-828 2.5/80mg and S-Amlodipine 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Sep 2012
- 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
- diagnosis of essential hypertension and blood pressure not adequately controlled (inadequate control defined as seated diastolic blood pressure(DBP)≥ 90mmHg if on existing amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
- failure to respond to four weeks treatment with S-Amlodipine 2.5mg(failure to respond defined as seated DBP ≥ 90mmHg)
- willing and able to provide written informed consent
Who cannot join
- mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 200mmHg during run-in treatment or mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 180mmHg at the randomization visit
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
- known severe or malignant retinopathy
Show all 18Show fewer
- hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5
- acute or chronic inflammatory status need to treatment
- need to additional antihypertensive drugs during the study
- need to concomitant medications known to affect blood pressure during the study
- history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
- known hypersensitivity related to either study drug
- history of drug or alcohol dependency within 6 months
- 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
- administration of other study drugs within 30 days prior to randomization
- premenopausal women(last menstruation < 1year) not using adequate contraception, pregnant or breast-feeding
- history of malignancy including leukemia and lymphoma within the past 5 years
- in investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's hospital, The catholic university of Korea
Seoul
About this study
Official title: Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy.
The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.
Read the detailed description
- In patients with essential hypertension inadequately controlled by S-Amlodipine monotherapy to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg)during 8weeks.
- Included S-Amlodipine run-in period(during 4 weeks_single blind) and Treatment period(during 8 weeks_double blind).
- Conditions
- Hypertension
- Being tested
- CKD-828 2.5/40mg, CKD-828 2.5/80mg, S-Amlodipine 2.5mg
- Keywords
- CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Non-Responder
- 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.
CKD-828 2.5/40mgDrug
fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg
CKD-828 2.5/80mgDrug
Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
S-Amlodipine 2.5mgDrug
Also called Anydipine S tab.
S-Amlodipine 2.5mg monotherapy
| Study group | Role | What they receive |
|---|---|---|
| CKD-828 2.5/40mg | Experimental | CKD-828 2.5/40mg Receives: Drug: CKD-828 2.5/40mg |
| CKD-828 2.5/80mg | Experimental | CKD-828 2.5/80mg Receives: Drug: CKD-828 2.5/80mg |
| S-Amlodipine 2.5mg | Active comparator | S-Amlodipine 2.5mg Receives: Drug: S-Amlodipine 2.5mg |
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 8 weeks of treatment
Secondary outcomes (4)
Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: After 4 weeks of treatment
Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: After 4 weeks and 8 weeks of treatment
Control Rate
SBP<140mmHg, DBP<90mmHg
Measured: After 8 weeks of treatment
Response Rate
Reduction of SBP≥20mmHg, DBP≥10mmHg
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 posted29 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ho-Joong Yoon, Ph.D, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501253
- Sponsor's protocol ID
- 130HT11A
- Status last verified
- Nov 2012
- First submitted
- 26 Dec 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy.
- ClinicalTrials.gov ID
- NCT01501253
- Acronym / sponsor ID
- 130HT11A
- Conditions
- Hypertension
- Keywords
- CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Non-Responder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Dec 2011 (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 two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.
Detailed description
- In patients with essential hypertension inadequately controlled by S-Amlodipine monotherapy to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg)during 8weeks.
- Included S-Amlodipine run-in period(during 4 weeks_single blind) and Treatment period(during 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
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD-828 2.5/40mg | Experimental | Drug: CKD-828 2.5/40mgCKD-828 2.5/40mg |
| CKD-828 2.5/80mg | Experimental | Drug: CKD-828 2.5/80mgCKD-828 2.5/80mg |
| S-Amlodipine 2.5mg | Active comparator | Drug: S-Amlodipine 2.5mgS-Amlodipine 2.5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- diagnosis of essential hypertension and blood pressure not adequately controlled (inadequate control defined as seated diastolic blood pressure(DBP)≥ 90mmHg if on existing amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
- failure to respond to four weeks treatment with S-Amlodipine 2.5mg(failure to respond defined as seated DBP ≥ 90mmHg)
- willing and able to provide written informed consent
Key exclusion criteria (18 listed)
- mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 200mmHg during run-in treatment or mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 180mmHg at the randomization visit
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
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 |
|---|---|---|
| CKD-828 2.5/40mgfixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg | Drug | CKD-828 2.5/40mg |
| CKD-828 2.5/80mgFixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg | Drug | CKD-828 2.5/80mg |
| S-Amlodipine 2.5mgAlso: Anydipine S tab.S-Amlodipine 2.5mg monotherapy | Drug | S-Amlodipine 2.5mg |
Primary outcome
Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: After 8 weeks of treatment
4 secondary outcomes
Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: After 4 weeks of treatment
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 Nov 2012.
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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.
Ho-Joong Yoon, Ph.D principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
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 CKD-828 2.5/40mg, CKD-828 2.5/80mg and S-Amlodipine 2.5mg 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 4 inclusion and 18 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 Nov 2012. 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 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 Nov 2012.