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An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan + hydrochlorothiazide and matching placebo | Experimental |
| |
| Telmisartan and matching placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan + hydrochlorothiazide | Drug |
| ||
| Telmisartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seated diastolic blood pressure (DBP) | baseline and after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seated systolic blood pressure (SBP) | baseline and after 8 weeks of treatment | |
| Blood pressure control | 8 weeks | |
| Systolic blood pressure response |
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Inclusion Criteria:
Exclusion Criteria:
Patients taking more than three anti-hypertensive medications at the screening visit
Pre-menopausal women
Any women:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters
Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
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) functional 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 symptoms characteristic of angioedema during treatment with ACE inhibitors, angiotension II antagonists, thiazide diuretics, β-blockers or calcium channel blockers
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 Type I or Type II 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
Patients receiving any investigational therapy within one month of signing the informed consent form. Patients who have participated in previous telmisartan (except if they were on the fixed dose combination in the 502.261 study or enrolled in the 502.321 open-label extension study) 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 |
|---|---|
| C436283 | telmisartan, hydrochlorothiazide drug combination |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| Placebo | Drug |
|
| 8 weeks |
| Incidence of adverse events | up to 16 weeks |
| Change from baseline in physical examination | Baseline and day 56 |
| Change from baseline in heart rate | Baseline, day 28 and 56 |
| Change from baseline in laboratory parameters | Baseline and day 56 |
| Change from baseline in 12-lead ECG (electrocardiogram) | Baseline and day 56 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |