CKD-330 Phase 3 Trial in Amlodipine Non-responder

Study Overview
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Brief Summary
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Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Detailed Description
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A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Official Title
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A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-330 16/5mg
* Drug: Amlodipine 5mg Placebo
* Drug: CKD-330 16/5mg Placebo
* Drug: Amlodipine 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 19 or above Essential hypertension with 140mmHg ≤ mean sitSBP < 180mmHg on target arm at Visit 2 Ability to provide written informed consent Exclusion Criteria: The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1 mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1 mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2 Known or suspected Secondary Hypertension Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c > 9% Patients with severe congestive heart failure(NYHA class III, IV) Patient with ischemic heart disease, Ischemic cardiovascular disease, Valvular heart disease, arrhythmia requiring treatment within 3 months History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months History of severe or malignant retinopathy AST/ALT ≥ UNL*3, Serum creatinine ≥ UNL*1.5, K > 5.5mEq/L Patients with acute or chronic inflammatory status requiring treatment Patient who need to take antihypertensive drug besides Investigational products Patient must be treated with medications prohibited for concomitant use during the study period History of angioedema related to ACE inhibitor or angiotensin II receptor blockers History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract History of malignant tumor within 5 years Patient who are dependent on drugs or alcohol within 6 months Hypersensitive to Candesartan/Amlodipine Women with pregnant, breast-feeding Patients treated with other investigational product within 30 days at first time taking the investigational product Not eligible to participate for the study at the discretion of investigator

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-330 16/5mg + Amlodipine 5mg placebo<br>CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d. | Drug: CKD-330 16/5mg<br>* Once a day, 8 weeks<br>Drug: Amlodipine 5mg Placebo<br>* Once a day, 8 weeks<br>* Other names: Norvasc 5mg Placebo;|
| Active Comparator: CKD-330 16/5mg placebo + Amlodipine 5mg<br>CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d. | Drug: CKD-330 16/5mg Placebo<br>* Once a day, 8 weeks<br>Drug: Amlodipine 5mg<br>* Once a day, 8 weeks<br>* Other names: Norvasc 5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change of sitSBP(sitting Systolic blood pressure) |  | From baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change of sitSBP(sitting Systolic blood pressure) |  | From baseline at week 4 | 
| The mean change of sitDBP(sitting diastolic blood pressure) |  | From baseline at week 4 and week 8 | 
| Blood Pressure Control rate | Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg | From baseline to week 8 | 
| Blood Pressure Response rate | sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg | From baseline to week 8 |