Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

Study Overview
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Brief Summary
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The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.

Official Title
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An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: fixed dose combination of telmisartan+amlodipine
* Drug: amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve). failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.) able to stop any current antihypertensive therapy without unacceptable risk to the patient. willing and able to provide written informed consent. Exclusion Criteria: pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential). known or suspected secondary hypertension. mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment. any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant. clinically relevant hyperkalaemia. uncorrected volume or sodium depletion. primary aldosteronism. hereditary fructose or lactose intolerance. symptomatic congestive heart failure. patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs. history of drug or alcohol dependency within the six months prior to signing consent. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.) non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period. chronic administration of any medication known to affect blood pressure, other than the trial medication. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fixed dose combination of telmisartan+amlodipine|nan|
|Drug: amlodipine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP | Baseline and end of study (8 weeks or last value on treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP | Baseline and end of study (8 weeks or last value on treatment) | 
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | The number of patients who reach the target DBP of <90mmHg | End of study (8 weeks or last value on treatment) | 
| Trough Seated Diastolic Blood Pressure <80 mmHg | The number of patients who reach the target DBP of <80mmHg | End of study (8 weeks or last value on treatment) | 
| Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | End of study (8 weeks or last value on treatment) | 
| Trough Seated SBP Control | The number of patients who reach the target SBP of <140mmHg | End of study (8 weeks or last value on treatment) | 
| Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | End of study (8 weeks or last value on treatment) | 
| Trough Seated BP Normality Classes | The number of patients who reach predefined BP categories | End of study (8 weeks or last value on treatment) | 
| Oedema Incidence Rate | The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) | During randomised treatment period | 
| Peripheral Oedema Incidence Rate | The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) | During randomised treatment period |