Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Study Overview
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Brief Summary
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The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Official Title
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An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg 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: patients aged at least 18 years at the date of signing the consent form diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision) willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation). Exclusion Criteria: are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. known or suspected secondary hypertension mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3) any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency) severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment) bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant clinically relevant hyperkalaemia uncorrected volume or sodium depletion. primary aldosteronism. hereditary fructose or lactose intolerance

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 (DBP) | Change from baseline to the end of study in trough DBP | End of study (8 weeks or last value on treatment) | 
| Number of Patients With Oedema | Patients from the treated set who experienced at least one case of general oedema. | During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | Change from baseline to the end of study in trough SBP | End of study (8 weeks or last value on treatment) | 
| Trough Seated Diastolic Blood Pressure Control | The number of patients who reach the target DBP of <90mmHg | 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 Blood Pressure (BP) Normality Classes | The number of patients who reach predefined BP categories: Optimal - SBP<120 and DBP<80 mmHg Normal - SBP<130 and DBP<85 mmHg High-normal - SBP<140 DBP<90 mmHg Stage 1 hypertension - SBP<160 and DBP<100 Stage 2 hypertension SBP>=160 and DBP>=100 mmHg | End of study (8 weeks or last value on treatment) |