The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.

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 losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

Detailed Description
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Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms). Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges. Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Official Title
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An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amosartan® tab
* Drug: Cozaar® plus pro tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 aged or over Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment) Exclusion Criteria: Patients with too high Blood pressure •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide. Secondary hypertension or suspected to be

Ages Eligible for Study
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Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amosartan® tab<br>Amlodipine 5mg /Losartan 100mg | Drug: Amosartan® tab<br>* comparison of different combination of anti-hypertension drug<br>* Other names: Amlodipine 5mg /Losartan 100mg;|
| Active Comparator: Cozaar® plus pro tab<br>Losartan 100mg/ HCTZ 12.5mg | Drug: Cozaar® plus pro tab<br>* comparison of different combination of anti-hypertension drug<br>* Other names: Losartan 100mg/ HCTZ 12.5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSDBP |  | Baseline, week 4 | 
| Change from baseline Mean Seated Systolic Blood Pressure (MSSBP) |  | Baseline, Week 4 and 8 | 
| Blood pressure responder rate | Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg and MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline. | Baseline, Week 4 and 8 |