CKD-828 S-Amlodipine Non-Responder Trial

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-828 2.5/40mg
* Drug: CKD-828 2.5/80mg
* Drug: S-Amlodipine 2.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-828 2.5/40mg<br>CKD-828 2.5/40mg | Drug: CKD-828 2.5/40mg<br>* fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg<br>|
| Experimental: CKD-828 2.5/80mg<br>CKD-828 2.5/80mg | Drug: CKD-828 2.5/80mg<br>* Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg<br>|
| Active Comparator: S-Amlodipine 2.5mg<br>S-Amlodipine 2.5mg | Drug: S-Amlodipine 2.5mg<br>* S-Amlodipine 2.5mg monotherapy<br>* Other names: Anydipine S tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Diastolic Blood Pressure (MSDBP) |  | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Diastolic Blood Pressure (MSDBP) |  | After 4 weeks of treatment | 
| Mean Sitting Systolic Blood Pressure (MSSBP) |  | After 4 weeks and 8 weeks of treatment | 
| Control Rate | SBP<140mmHg, DBP<90mmHg | After 8 weeks of treatment | 
| Response Rate | Reduction of SBP≥20mmHg, DBP≥10mmHg | After 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Non-Responder