Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of treatment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan low dose | Drug |
| ||
| Telmisartan high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in seated diastolic blood pressure (DBP) at trough | 12 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seated systolic blood pressure (SBP) at trough | 12 weeks after start of treatment | |
| Frequency of response categories of blood pressure | Categories:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in-phase) who:
Known or suspected renovascular hypertension
Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in phase
Hepatic dysfunction as defined by the following laboratory parameters:
serum glutamate pyruvate transaminase (ALT) or serum glutamate oxaloacetate transaminase (AST) > than 2 times the upper limit of normal range
Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
Clinically relevant hypo- or hyperkalaemia
Uncorrected volume depletion
Uncorrected sodium depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II antagonists
History of drug or alcohol abuse within 6 months
Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (ß-blocker, alpha-blocker, calcium antagonists, clonidine, minoxidil, and diuretics)
Any investigational therapy within one month of signing the informed consent form
Known hypersensitivity to any component of the formulation
Has no contra-indication to a placebo run-in period (e.g. unstable angina within the past 3 months, stroke within the past 6 months or myocardial infarction or cardiac surgery within the past 3 months)
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
Compliance < 70% during run-in period (defined by pill count)
History of heart failure, malignancy, or any disorders requiring immunosuppressive therapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
patients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment |
|
| Placebo | Drug | Run-in phase |
|
| After 12 weeks of treatment |
| Changes from baseline in proteinuria | 12 weeks after start of treatment |
| Change in electrolyte excretion | 12 weeks after start of treatment |
| Area under the telmisartan plasma concentration-time curve | Day 7 and 12 weeks after start of treatment |
| Maximum plasma concentration (Cmax) of telmisartan | Day 7 and 12 weeks after start of treatment |
| Time to peak (Tmax) plasma concentrations of telmisartan | Day 7 and 12 weeks after start of treatment |
| Extent of protein binding of telmisartan | equilibrium dialysis with subsequent determination of protein-bound telmisartan fraction | Day 7 and 12 weeks after start of treatment |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |