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The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental | 4-week placebo run-in, 8-week fixed dose period |
|
| Amlodipine | Active Comparator | 4-week placebo run-in, 8-week fixed dose period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in diastolic and systolic blood pressure during the last six hours of a 24-hour dosing interval, measured by ambulatory blood pressure monitoring | Baseline (day 1), day 57 of the open-label period |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in diastolic and systolic blood pressure during other times during the 24-hour ABPM profile | Baseline (day 1), up to day 57 of the open-label period | |
| Changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff |
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Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening):
Any women:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters
At screening (Visit 1): clinically relevant sodium depletion, hyperkalemia, or hypokalemia
Known or suspected secondary hypertension
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF 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
PTCA (percutaneous transluminal coronary angioplasty) 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
Administration of digoxin or other digitalis-type drugs
Patients with insulin-dependent diabetes mellitus whose diabetes has 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 one year period
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 AM (ante meridian)
Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous MICARDIS (telmisartan) studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
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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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug |
|
| Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period |
| Blood pressure responder rates based on ABPM | day 56 and 57 of the open-label period |
| Blood pressure responder rates based on manual cuff measurements | days 14, 28, 56 and 57 of the open-label period |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |