CKD-828 Primary Hypertension Trial(Dose-selection)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: S-Amlodipine, Telmisartan
* Drug: S-Amlodipine
* Drug: Telmisartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-Amlodipine 2.5mg + Telmisartan 40mg<br> | Drug: S-Amlodipine, Telmisartan<br> <br> |
| Experimental: S-Amlodipine 2.5mg + Telmisartan 80mg<br> | Drug: S-Amlodipine, Telmisartan<br> <br> |
| Experimental: S-Amlodipine 5mg + Telmisartan 40mg<br> | Drug: S-Amlodipine, Telmisartan<br> <br> |
| Experimental: S-Amlodipine 5mg + Telmisartan 80mg<br> | Drug: S-Amlodipine, Telmisartan<br> <br> |
| Active Comparator: S-Amlodipine 2.5mg<br> | Drug: S-Amlodipine<br> <br> |
| Active Comparator: S-Amlodipine 5mg<br> | Drug: S-Amlodipine<br> <br> |
| Active Comparator: Telmisartan 40mg<br> | Drug: Telmisartan<br> <br> |
| Active Comparator: Telmisartan 80mg<br> | Drug: Telmisartan<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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 | 
| Response rate | Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg | After 4 weeks and 8 weeks of treatment | 
| Control rate | Reduction SBP < 140mmHg, DBP < 90mmHg | After 4 weeks and 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, Amlodipine, Factorial, Phase 2