E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
to show that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior to a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in reducing seated trough diastolic blood pressure (DBP) in patients who fail to respond to T80/H12.5.
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E.2.2 | Secondary objectives of the trial |
(i) to show that T80/H25 is superior to T80/H12.5 mg in reducing other blood pressure endpoints including seated trough systolic blood pressure (SBP), standing SBP and DBP, proportions of patients achieving blood pressure control, DBP response and SBP response and proportions of patients with optimal, normal, high-normal and high blood pressure and (ii) to monitor safety through physical examinations, laboratory parameters, 12-lead electrocardiogram (ECG) and reported adverse events.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
male or female patients aged at least 18 years. diagnosis of essential hypertension and currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before entry. blood pressure not adequately controlled on existing antihypertensive treatment before entry. (Inadequate control defined as seated DBP ≥ 95 mmHg on one current antihypertensive medication or DBP ≥ 90 mmHg on two or more current antihypertensive medications). failure to respond to six weeks treatment with T80/H12.5 fixed-dose combination therapy. (Failure to respond defined as seated DBP ≥ 90 mmHg at six weeks.) willing and able to provide written informed consent
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E.4 | Principal exclusion criteria |
women of child-bearing potential who are NOT practising acceptable means of birth control or do NOT plan to continue using acceptable means of birth control throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives. women with a positive serum pregnancy test at entry or at any subsequent visit or women who are breast-feeding. known or suspected secondary hypertension. mean SBP equal to or greater than 200 mmHg at the end of the run-in treatment period. severe hepatic or renal impairment (including bilateral renal artery stenosis, renal artery stenosis in a solitary kidney or patients post-renal transplant or with only one functioning kidney) clinically relevant hypokalaemia or hyperkalaemia. uncorrected volume or sodium depletion. primary aldosteronism. hereditary fructose intolerance. patients who have previously experienced symptoms characteristic of angioedema during treatment with any ACE inhibitors or angiotensin-II receptor antagonist. history of drug or alcohol dependency within the previous six months. current treatment with any antihypertensive agent that cannot be safely stopped (investigator’s decision) by the start of the run-in treatment period or chronic administration of any medication known to affect blood pressure, other than the trial medication. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. known allergic hypersensitivity to any component of the formulations under investigation (including known hypersensitivity to any angiotensin-II receptor antagonist, hydrochlorothiazide or sulphonamide-derived drugs). concomitant therapy with lithium, cholestyramine or colestipol resins. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or hydrochlorothiazide.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in seated trough (i.e. at 24-hours after last dose) DBP after eight weeks of treatment or at last trough observation. |
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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 | Information not present in EudraCT |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |