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The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan 40-80 mg) and COZAAR® (losartan 50-100 mg) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM after 8-weeks treatment. Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of Micardis® | Experimental |
| |
| High dose of Micardis® | Experimental |
| |
| Low dose of COZAAR® | Active Comparator |
| |
| High dose of COZAAR® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose of Micardis®, once daily | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean diastolic blood pressure | Measured during the last 6 hours of the 24-hour dosing interval using ABPM | Up to 8 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean systolic blood pressure | Measured during the last 6 hours of the 24-hour dosing interval using ABPM | Up to 8 weeks after start of treatment |
| Changes from baseline in diastolic and systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the placebo run-in period
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Clinically relevant sodium depletion, hyperkalemia, or hypokalemia
Uncorrected volume depletion
Primary aldosteronism
Biliary obstructive disorders
Known or suspected secondary hypertension
Hereditary fructose intolerance
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
Congestive heart failure (NYHA functional class congestive heart failure (CHF) class III-IV)
Unstable angina within the past three months
Stroke within the past six months
Myocardial infarction or cardiac surgery within the past three months
Percutaneous transluminal coronary angioplasty (PTCA) within the past three months
History of angioedema
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients with insulin-dependent diabetes mellitus whose diabetes hast not been stable and controlled for at least the past three months as defined by an HbA1c ≥ 10%
Known drug or alcohol dependency within the past 6 months
Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridien (AM)
Patients receiving any investigational therapy within one month of signing the informed consent form
Known hypersensitivity to any component of the formulations
Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
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| Low dose of Micardis®, once daily |
| Drug |
|
|
| Low dose of COZAAR®, once daily | Drug |
|
|
| High dose of COZAAR®, once daily | Drug |
|
|
| Placebo | Drug |
|
Measured during other times of the 24-hour ABPM profile (e.g. 24-hour mean, morning mean, daytime mean and nighttime mean)
| Up to 8 weeks after start of treatment |
| Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure | Triplicate measurement in two minute intervals after 5 minutes of rest, in seated position using sphygmomanometer | Up to 8 weeks after start of treatment |
| Assessment of responder rates on ABPM | Baseline, 8 weeks after start of treatment |
| Assessment of responder rates on trough cuff blood pressure | Baseline up to 8 weeks after start of treatment |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |
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