Efficacy and Safety of Amlodipine and Losartan 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 safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Official Title
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An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine plus Losartan
* Drug: Amlodipine
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 75 Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period} Exclusion Criteria: Patients with mean sitSBP ≥ 200 mmHg Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers Patients with secondary hypertension or suspected secondary hypertension Patients with malignant hypertension Patients who have received any medications with possible interactions with study drugs Patients with uncontrolled diabetes Patients with severe heart disease or severe cerebrovascular disease Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST) Patients with a history of malignant disease Patients with a history of autoimmune disease Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: Amlodipine plus Losartan|amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg|
|Drug: Amlodipine|amlodipine 5mg, 10mg|
|Drug: Losartan|Losartan 50mg, 100mg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average changes from baseline in sitDBP |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average changes from baseline in sitDBP |  | Week 4 | 
| Average changes from baseline in sitSBP |  | Week 4, 8 | 
| Blood pressure responder rate |  | Week 4, 8 | 

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