A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension

Study Overview
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Brief Summary
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The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.

Official Title
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A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5 mg in Comparison With Losartan 50 mg Plus Hydrochlorothiazide 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan 40 mg/hydrochlorothiazide 12.5 mg
* Drug: losartan 50 mg/hydrochlorothiazide 12.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate hypertension as defined by a morning mean(>95 and <115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be >140 and <200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake. Male or female between 20 to 80 years old Ability to provide written informed consent. Exclusion Criteria: Patients are still taking more than three anti-hypertensives at the screening visit Pre-menopausal women Known or suspected secondary hypertension Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase Hepatic and/or renal dysfunction Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant Known NYHA functional class Chronic Heart Failure (CHF) III, IV Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve. Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L Clinically significant hyperkalemia as defined by serum potassium level >5.5 mmol/L Non-insulin dependent DM poorly controlled whicih is defined as HbA1c>8% twice consecutively within 6 months and/or AC blood sugar>180 mg/dl. Insulin Dependent Diabetes Mellitus Chronic administration of oral anticoagulants and/or digoxin within the past 6 months. Known drug or alcohol dependency Administration of medication known to affect blood pressure, except medication allowed by the protocol Angioedema with ACE inhibitors Use of nitrates

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan 40 mg/hydrochlorothiazide 12.5 mg|nan|
|Drug: losartan 50 mg/hydrochlorothiazide 12.5 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated. |  | 8 weeks |