Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Study Overview
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Brief Summary
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A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

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

Conditions
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Hypertension

Intervention / Treatment
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* 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 19 or above Inadequately controlled Essential hypertension at Screening Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1 Mean sitDBP ≥ 95mmHg on target arm Taking antihypertensive drug but not controlled Mean sitDBP ≥ 90mmHg on target arm Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy Mean sitDBP at Visit 2 ≥ 90mmHg on target arm Ability to provide written informed consent Exclusion Criteria: The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1 Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2 Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) Patient with congestive heart failure(NYHA class III, IV) Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months History of stroke, cerebral hemorrhage within 6 months Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5% History of severe or malignant retinopathy AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L Patient with acute or chronic inflammatory(treatment required) status 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 Hypersensitive to Candesartan/Amlodipine Patient who are dependent on drugs or alcohol within 6 months History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract Patients treated with other investigational product within 30 days at first time taking the investigational product Women with pregnant, breast-feeding History of malignant tumor within 5 years 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: Candesartan 16mg + Amlodipine 5mg<br>Candesartan 16mg + Amlodipine 5mg, po, q.d. | Drug: Candesartan 16mg<br> <br> Drug: Amlodipine 5mg<br> <br> |
| Experimental: Candesartan 16mg + Amlodipine 10mg<br>Candesartan 16mg + Amlodipine 10mg, po, q.d. | Drug: Candesartan 16mg<br> <br> Drug: Amlodipine 10mg<br> <br> |
| Active Comparator: Candesartan 16mg<br>Candesartan 16mg, po, q.d. | Drug: Candesartan 16mg<br> <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 to week 4 | 
| The mean change of sitSBP |  | From baseline to week 4 and 8 | 
| Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg |  | From baseline to week 8 | 
| Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg |  | From baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension