Efficacy and Safety of CKD-828 to Stage 2 Hypertension

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, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Detailed Description
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In patients with Stage 2 hypertension to determine the efficacy and safety of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 10 weeks. This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(10 weeks_double blind.

Official Title
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A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-828 2.5/40mg
* Drug: CKD-828 5/40mg
* Drug: CKD-828 5/80mg
* Drug: S-amlodipine 2.5mg
* Drug: S-amlodipine 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older at the screening visit antihypertensive drugs not taking: 160mmHg ≤ sitSBP < 200mmHg antihypertensive drugs taking: 140mmHg ≤ sitSBP < 180mmHg at the randomization visit(160mmHg ≤ sitSBP < 200mmHg) willing and able to provide written informed consent Exclusion Criteria: mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs 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), ischaemic heart diseasesstatus need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty 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 defined by the following laboratory parameters: hepatic dysfunction(AST/ALT > UNL X 3) renal dysfunction(serum creatinine > UNL X 1.5) hypopotassemia(K < 3.0mmol/L) or hyperpotassemia (K>5.5 mmol/L) 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 4weeks 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 2.5/40, 2.5/80, 5/80mg<br> | Drug: CKD-828 2.5/40mg<br>* Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks. With the others investigation product placebo 4 tabs QD 2 weeks.<br>* Other names: CKD-828;Drug: CKD-828 5/40mg<br>* Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks. With the others investigation product placebo 4 tabs QD 2 weeks.<br>* Other names: CKD-828;Drug: CKD-828 5/80mg<br>* Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks. With the others investigation product placebo 4 tabs QD 6 weeks.<br>* Other names: CKD-828;|
| Active Comparator: S-Amlodipine 2.5, 5mg<br> | Drug: S-amlodipine 2.5mg<br>* S-amlodipine 2.5mg QD 4 weeks With the others investigation product placebo 4 tabs QD 4 weeks.<br>* Other names: Anydipine S;Drug: S-amlodipine 5mg<br>* S-amlodipine 2.5mg QD 6weeks With the others investigation product placebo 4 tabs QD 6 weeks.<br>* Other names: Anydipine S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting systolic Blood Pressure (MSSBP) |  | After 10 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting systolic Blood Pressure (MSSBP) |  | After 2 weeks, 4 weeks and 6 weeks of treatment | 
| Mean Sitting diastolic Blood Pressure (MSDBP) |  | After 2weeks, 4weeks, 6weeks and 10 weeks of treatment | 
| Control Rate | Sitting SBP<140mmHg, Sitting DBP<90mmHg | After 10 weeks of treatment | 
| Response Rate | Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg | After 10 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, Stage 2 Hypertension, S-Amlodipine, Telmisartan