HypertensionPhase 2NCT01128322
CKD-828 Primary Hypertension Trial(Dose-selection)
A Phase 2 study testing S-Amlodipine, Telmisartan, S-Amlodipine and Telmisartan in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 26 sites in South Korea.
Trial summary
The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- S-Amlodipine, Telmisartan, S-Amlodipine and Telmisartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 26 sitesSouth Korea
- Study dates
- Jul 2010to Mar 2011
- Phase
- Phase 2
- 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
- stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
- ability to provide written informed consent
Who cannot join
- severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
- 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 Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
- known severe or malignant retinopathy
Show all 19Show 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
- 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, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
- cannot swallow investigational products
- administration of other study drugs within 4 weeks prior to randomization
- premenopausal women(last menstration < 1year) not using adequte 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
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites
Hallym University Sacred Heart Hospital
Anyang
Soonchunhyang University Hospital in Bucheon
Bucheon-si
Kosin University Gospel Hospital
Busan
Chungbuk National Uiversity Hospital
Cheongju-si
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
DonGuk University International Hospital
Goyang
National Health Insurance Corporation Ilsan Hospital
Goyang
Chonnam National University Hospital
Gwangju
Gachon University Gil Medical Center
Inchon
Chonbuk National University Hospital
Jeonju
Pusan National University Hospital
Pusan
Seoul National University Bundang Hospital
Seongnam
Ewha Womans University Hospital
Seoul
Gangnam Severance Hospital
Seoul
Kandong Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Medical Center
Seoul
Seoul St. Mary's Hospital, The catholic University of Korea
Seoul
Severance Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
Soon Chun Hyang University Hospital
Seoul
St. Paul's Hospital, The catholic University of Korea
Seoul
Ajou University Hospital
Suwon
Uijeongbu St. Mary's Hospital, The catholic University of Korea
Uijeongbu-si
Wonju Christian Hospital
Wŏnju
About this study
Official title: A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension
The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).
- Conditions
- Hypertension
- Being tested
- S-Amlodipine, Telmisartan, S-Amlodipine, Telmisartan, Placebo
- Keywords
- CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Amlodipine, Factorial, Phase 2
- 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.
S-Amlodipine, TelmisartanDrug
S-AmlodipineDrug
TelmisartanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| S-Amlodipine 2.5mg + Telmisartan 40mg | Experimental | Not described Receives: Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 2.5mg + Telmisartan 80mg | Experimental | Not described Receives: Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 5mg + Telmisartan 40mg | Experimental | Not described Receives: Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 5mg + Telmisartan 80mg | Experimental | Not described Receives: Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 2.5mg | Active comparator | Not described Receives: Drug: S-Amlodipine |
| S-Amlodipine 5mg | Active comparator | Not described Receives: Drug: S-Amlodipine |
| Telmisartan 40mg | Active comparator | Not described Receives: Drug: Telmisartan |
| Telmisartan 80mg | Active comparator | Not described Receives: Drug: Telmisartan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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
Response rate
Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg
Measured: After 4 weeks and 8 weeks of treatment
Control rate
Reduction SBP < 140mmHg, DBP < 90mmHg
Measured: After 4 weeks and 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 posted21 May 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionMar 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128322
- Sponsor's protocol ID
- 128HT09K
- Status last verified
- Apr 2011
- First submitted
- 20 May 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01128322
- Acronym / sponsor ID
- 128HT09K
- Conditions
- Hypertension
- Keywords
- CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Amlodipine, Factorial, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 May 2010 (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 this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| S-Amlodipine 2.5mg + Telmisartan 40mg | Experimental | Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 2.5mg + Telmisartan 80mg | Experimental | Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 5mg + Telmisartan 40mg | Experimental | Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 5mg + Telmisartan 80mg | Experimental | Drug: S-Amlodipine, Telmisartan |
| S-Amlodipine 2.5mg | Active comparator | Drug: S-Amlodipine |
| S-Amlodipine 5mg | Active comparator | Drug: S-Amlodipine |
| Telmisartan 40mg | Active comparator | Drug: Telmisartan |
| Telmisartan 80mg | Active comparator | Drug: Telmisartan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
- ability to provide written informed consent
Key exclusion criteria (19 listed)
- severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
- 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 Diabets 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 |
|---|---|---|
| S-Amlodipine, Telmisartan | Drug | S-Amlodipine 2.5mg + Telmisartan 40mg, S-Amlodipine 2.5mg + Telmisartan 80mg, S-Amlodipine 5mg + Telmisartan 40mg, S-Amlodipine 5mg + Telmisartan 80mg |
| S-Amlodipine | Drug | S-Amlodipine 2.5mg, S-Amlodipine 5mg |
| Telmisartan | Drug | Telmisartan 40mg, Telmisartan 80mg |
| Placebo | Drug | Placebo |
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
Response rate
Time frame: After 4 weeks and 8 weeks of treatment
Control rate
Time frame: After 4 weeks and 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 26 Apr 2011.
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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.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-Amlodipine, Telmisartan, S-Amlodipine and Telmisartan in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 26 sites 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 3 inclusion and 19 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Apr 2011.