Telmisartan 80mg Non-responder Trial

Study Overview
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Brief Summary
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If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly. In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg. Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Official Title
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An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg+ Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan and amlodipine
* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Essential hypertensive patients If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion. Exclusion criteria: Patients taking 3 or more antihypertensive drugs at signing the informed consent form Patients with known or suspected secondary hypertension Patients with clinically relevant cardiac arrhythmia Congestive heart failure with New York Heart Association (NYHA) functional class III-IV Patients with recent cardiovascular events Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs Patients with hepatic and/or renal dysfunction Pre-menopausal women who are nursing or pregnant

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan and amlodipine FDC<br>once a daily | Drug: Telmisartan and amlodipine<br>* Telmisartan 80 mg and amlodipine 5 mg once a daily<br>|
| Active Comparator: Telmisartan monotherapy<br>once a daily | Drug: Telmisartan<br>* 80 mg once a daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough | Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough | Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | Baseline, 8 weeks | 
| Seated DBP Control Rate at Trough | DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks | 
| Seated SBP Control Rate at Trough | SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks | 
| Seated DBP Response Rate at Trough | DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks | 
| Seated SBP Response Rate at Trough | SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks | 
| Seated Blood Pressure (BP) Normalisation at Trough | Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |