Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

Official Title
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The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: amlodipine/losartan
* Drug: amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 aged or over Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg Exclusion Criteria: Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics Secondary hypertension or suspected to be Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus History of severe neurovascular disease, severe heart disease Known as moderate or malignant retinopathy. Renal diseases; serum creatinine ≥ 2mg/dl Hepatic diseases; increase in ALT or AST ≥ 2xUNL Anuria Hyponatremia/hypokalemia or hypercalcemia Active Gout Surgical or medical diseases which might significantly change ADME of medicines History of malignant tumor Autoimmune diseases History of alcohol or drug abuse Positive to pregnancy test, nursing mother, woman with an intention of pregnancy Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision Other protocol-defined inclusion/exclusion criteria may apply

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amlodipine/losartan<br> | Drug: amlodipine/losartan<br>* amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)<br>* Other names: amosartan;|
| Active Comparator: amlodipine<br> | Drug: amlodipine<br>* amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)<br>* Other names: amodipin(amlodipine camsylate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP |  | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP |  | Baseline, Week 2 and 8 | 
| Change from baseline MSDBP |  | Baseline, Week 2, 6, and 8 | 
| Blood pressure responder rate | Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline. | Baseline, Week 2, 6, 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amlodipine, losartan, hypertension, stage 2