A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.

Official Title
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A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Candesartan 8mg
* Drug: Candesartan 16mg
* Drug: Amlodipine 5mg
* Drug: Amlodipine 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 or above Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3 Ability to provide written informed consent Exclusion Criteria: nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3 The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1 Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) Patients with congestive heart failure(NYHA class III IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8% History of severe or malignant retinopathy AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L Patients with acute or chronic inflammatory status, autoimmune disease Patients who need to take antihypertensive drug besides Investigational products Patients must be treated with medications prohibited for concomitant use during study period Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers History of malignant tumor within 5 years Patients who are dependent on drugs or alcohol History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract Patients treated with other investigational product within 4 weeks at the time concents are obtained Women with pregnant, breast-feeding Not eligible to participate for study at the discretion of investigator

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candesartan 8mg + Amlodipine 5mg<br>Candesartan 8mg + Amlodipine 5mg, po, q.d. | Drug: Candesartan 8mg<br>* Once a day, 8 weeks<br>Drug: Amlodipine 5mg<br>* Once a day, 8 weeks<br>|
| Experimental: Candesartan 8mg + Amlodipine 10mg<br>Candesartan 8mg + Amlodipine 10mg, po, q.d. | Drug: Candesartan 8mg<br>* Once a day, 8 weeks<br>Drug: Amlodipine 10mg<br>* Once a day, 8 weeks<br>|
| Experimental: Candesartan 16mg + Amlodipine 5mg<br>Candesartan 16mg + Amlodipine 5mg, po, q.d. | Drug: Candesartan 16mg<br>* Once a day, 8 weeks<br>Drug: Amlodipine 5mg<br>* Once a day, 8 weeks<br>|
| Experimental: Candesartan 16mg + Amlodipine 10mg<br>Candesartan 16mg + Amlodipine 10mg, po, q.d. | Drug: Candesartan 16mg<br>* Once a day, 8 weeks<br>Drug: Amlodipine 10mg<br>* Once a day, 8 weeks<br>|
| Active Comparator: Candesartan 8mg<br>Candesartan 8mg, po, q.d. | Drug: Candesartan 8mg<br>* Once a day, 8 weeks<br>|
| Active Comparator: Candesartan 16mg<br>Candesartan 16mg, po, q.d. | Drug: Candesartan 16mg<br>* Once a day, 8 weeks<br>|
| Active Comparator: Amlodipine 5mg<br>Amlodipine 5mg, po, q.d. | Drug: Amlodipine 5mg<br>* Once a day, 8 weeks<br>|
| Active Comparator: Amlodipine 10mg<br>Amlodipine 10mg, po, q.d. | Drug: Amlodipine 10mg<br>* Once a day, 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change of sitDBP |  | From baseline at week 4 and week 8 | 
| The mean change of sitSBP |  | From baseline at week 4 and 8 | 
| Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg |  | From baseline at week 4 and 8 | 
| Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg |  | At week 4 and 8 |