E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005757 |
E.1.2 | Term | Blood pressure systolic abnormal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005728 |
E.1.2 | Term | Blood pressure abnormal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005736 |
E.1.2 | Term | Blood pressure diastolic abnormal |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the blood pressure control rate after 12 weeks of treatment with telmisartan/amlodipine FDC in patients who were previously not controlled on RAAS blocking mono-therapy (ARBs, ACEi, DRI). |
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E.2.2 | Secondary objectives of the trial |
1 Percentage of patients achieving BP control (SBP<140 mmHg and DPB<90 mmHg) using in-clinic BP at weeks 4 and 8. 2 Percentage of patients achieving BP control using HBPM (SBP<135 mmHg and DPB<85 mmHg) at week 12. 3 Change from baseline in the in-clinic measured mean pulse pressure and mean blood pressure after 4, 8 and 12 weeks. 4 Response variables after 4, 8, and 12 weeks of treatment for in-clinic measurements 5 Percentage of patient in BP categories after 4, 8 and 12 weeks. 6 Response variables after 4, 8, and 12 weeks of treatment for home measured BP (HBPM) 7 Proportion of patients requiring up titration to T80/A10 to achieve BP control. 8 safety endpoints (AE and change from baseline
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation 2. Age 18 years or older 3. 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 (ACE inhibition, ARB and Renin-inhibitors) 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.
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E.4 | Principal exclusion criteria |
1. 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. 2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma). 3. Mean in-clinic seated cuff SBP ≥180 mmHg and SBP ≥160 mmHg in patients with diabetes or renal impairment or DBP ≥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. 4. 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. 5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. 6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L). 7. Uncorrected sodium or volume depletion. 8. Primary aldosteronism. 9. Hereditary fructose intolerance. 10. Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.1). 11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator. 12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x ASAT/ALAT values). (Refer to Appendix 10.3) 13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists. 14. History of drug or alcohol dependency within six months prior to signing the informed consent form. 15. Any investigational drug therapy within one month of signing the informed consent. 16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine). 17. History of non-compliance or inability to comply with prescribed medications or protocol procedures. 18. 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for this trial is the percentage of patients achieving blood pressure control (defined as SBP<140 mmHg and DBP<90 mmHg) after 12 weeks of treatment, determined by in-clinic BP measurements. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
uptitrated to higher dose when not on control |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
higher dose of the same FDC |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial visit is in this trial the visit where the patient had his last study medication the day before. The patient will be checked for BP control and given adequate antihypertensive treatment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 11 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 11 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 5 |