PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension

Study Overview
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Brief Summary
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The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach. The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.

Official Title
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An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Amlodipine/Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 20-80 years of age Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy. Agree to and are able to follow the study procedures Understand the nature of the study, and have signed informed consent forms Exclusion Criteria: Patients with any of the following conditions: Malignant (or history of malignant) hypertension Secondary hypertension Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg) A history of hypertensive encephalopathy or cerebrovascular accident Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization New York Heart Association class III -IV congestive heart failure Second- or third-degree heart block Angina pectoris Significant arrhythmia or valvular heart disease Significant pancreatic, hepatic, or renal disease Diabetes requiring insulin treatment or poorly controlled type 2 diabetes Patients with known contraindication or a history of allergy to CCBs or ARBs. Female patients who are pregnant or lactating. Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study Patients is currently participating in any other clinical trial within 30 days

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Amlodipine/Valsartan Single-Pill Combination | Drug: Amlodipine/Valsartan<br>* Amlodipine/Valsartan: 5 mg/80 mg<br>* Other names: Am-Daiwen®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period. |  | 6 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment |  | 6 weeks from baseline | 
| To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment |  | 6 weeks from baseline |