Filtered Trial for Amlodipine Non-responder

Study Overview
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Brief Summary
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To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.

Official Title
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Filtered Trial for Amlodipine Non-responder

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan+amlodipine
* Drug: amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Essential hypertensive patients satisfying all of the following criteria; Male or Female Age > 20 years Outpatient Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law. Exclusion Criteria: Taking four or more anti-hypertensive medications Secondary hypertension Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV History of myocardial infarction or cardiac surgery within last 6 months History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months History of unstable angina within last 3 months Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve History of stroke or transient ischemic attack within last 6 months History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs Hepatic and/or renal dysfunction Diagnosed biliary atresia or cholestasis Hyperkalemia Dehydration Sodium deficiency Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs) Patients who cannot change to the restricted administration and dosage during study period Pre-menopausal women who meet any one of the following 1 - 3: Pregnant or possibly pregnant (1) Nursing (2) Desire to become pregnant during study period (3) Drug or alcohol dependency Complication of malignant tumour or a disease requiring immunosuppressants Compliance of < 80% or > 120% during the run-in period Receiving any investigational therapy within 3 months Judged to be inappropriate by the investigator or the sub-investigator

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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan+amlodipine|nan|
|Drug: amlodipine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Baseline and 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Baseline and 8 Weeks | 
| Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake | 8 weeks | 
| Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake | 8 weeks | 
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks | 8 weeks | 
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks | Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline) | 8 weeks | 
| Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) | Optimal, normal, high normal blood pressure were defined as follows: Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg No: SBP >= 140 mmHg and DPB >= 90 mmHg | 8 weeks | 
| Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | First administration of randomised treatment to 24 hours post last dose of randomised treatment |