A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

Study Overview
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Brief Summary
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The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg

Official Title
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A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg. Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg. Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg Patients with a screening treatment compliance rate >= 80% Exclusion Criteria: Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- |
| Active Comparator: Amlodipine 5mg<br> | Drug: Amlodipine<br>* Amlodipine 5mg/ day<br>|
| Experimental: Amlodipine 10mg<br> | Drug: Amlodipine<br>* Amlodipine 10mg/ day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 | Mean change in the trough SBP | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8 | Mean change in the trough DBP | Baseline to Week 8 | 
| Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient) | Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in SBP at Week 6 and Change from baseline in SBP at Week 8 | Baseline to Week 6 and Week 8 | 
| Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient) | Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in DBP at Week 6 and Change from baseline in DBP at Week 8 | Baseline to Week 6 and Week 8 | 
| Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8 | Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old | Week 8 | 
| Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8 | Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old | Week 6 and Week 8 | 
| Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8 | Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old | Week 8 | 
| Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8 | Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old | Week 6 and Week 8 | 
| Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg |  | Baseline, Week 4 and Week 8 | 
| Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg |  | Baseline, Week 4, and Week 8 |