Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension

Study Overview
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Brief Summary
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A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Official Title
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A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Irbesartan/Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 19 years or older / 75 years or younger on screening Signed informed consent Patients with Essential Hypertension Other inclusion applied Exclusion Criteria: Orthostatic hypertension with symptom Other exclusion applied

Ages Eligible for Study
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Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan low/Amlodipine low<br>Irbesartan low & Amlodipine low, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Experimental: Irbesartan low/Amlodipine high<br>Irbesartan low & Amlodipine high, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Experimental: Irbesartan high/Amlodipine low<br>Irbesartan high & Amlodipine low, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Experimental: Irbesartan high/Amlodipine high<br>Irbesartan high & Amlodipine high, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Active Comparator: Amlodipine low<br>Amlodipine low, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Active Comparator: Amlodipine high<br>Amlodipine high, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Active Comparator: Irbesartan low<br>Irbesartan low, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|
| Active Comparator: Irbesartan high<br>Irbesartan high, once daily for 8 weeks | Drug: Irbesartan/Amlodipine<br>* QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in MSSBP between baseline and Week8. | The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8. | Baseline and Week8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in MSSBP between baseline and Week4. |  | Baseline and Week4 | 
| The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8. |  | Baseline and Week4/8 | 
| The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8. |  | Baseline and Week4/8 |