TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

Study Overview
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Brief Summary
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The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.

Detailed Description
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Study Design:

Official Title
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A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension...

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan/amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation Age 18 years or older Patients with uncontrolled hypertension as defined SBP > 140 mmHg and SBP > 130 mmHg in patients with diabetes or renal impairment or DBP > 90 mmHg and DBP >80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min Exclusion criteria: Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or 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 (e.g., renal artery stenosis or phaeochromocytoma). Mean in-clinic seated cuff Systolic BP >180 mmHg and SBP >160 mmHg in patients with diabetes or renal impairment or Diastolic BP >110 mmHg and DBP >100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ¿mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L). Uncorrected sodium or volume depletion. Primary aldosteronism. Hereditary fructose intolerance. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1). Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (Refer to Appendix 10.3) Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists. History of drug or alcohol dependency within six months prior to signing the informed consent form. Any investigational drug therapy within one month of signing the informed consent. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine). History of non-compliance or inability to comply with prescribed medications or protocol procedures. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telmisartan/amlodipine<br>start low dose and uptitrate to high dose on the basis of blood pressure goal | Drug: telmisartan/amlodipine<br>* start low dose and uptitrate to high dose on the basis of BP goal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | 4 and 8 weeks | 
| BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg. | Week 12 | 
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP |  | weeks 4, 8 and 12 | 
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. | weeks 4, 8 and 12 | 
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure |  | weeks 4, 8 and 12 | 
| DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. | weeks 4, 8 and 12 | 
| Percentage of Patients in Blood Pressure Categories Over Time | BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. | weeks 4, 8 and 12 | 
| DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg | weeks 4, 8 and 12 | 
| Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time |  | weeks 4 and 8 |