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 | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015488 |
E.1.2 | Term | Essential hypertension |
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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 trial is to assess the efficacy and safety of the fixed dose combinations T40/A5 or T80/A5 during long-term open-label treatment. |
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E.2.2 | Secondary objectives of the trial |
An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A5 or T80/A5 with any other therapies commonly used in the treatment of hypertension. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. patients aged at least 18 years 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial 1235.5 (inadequate control defined as seated DBP ≥ 95 mmHg if on existing antihypertensive treatment or seated DBP ≥ 100 mmHg if treatment-naive) 3. failure to respond to six weeks treatment with A5 in the run-in period of the preceding trial 1235.5 (failure to respond defined as seated DBP ≥ 90 mmHg) 4. are randomised to the preceding trial 1235.5 and have completed that trial in the fourteen (14) days prior to Visit 1 5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation)
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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. development of any medical condition in the preceding 1235.5 trial that in the investigator's opinion could be worsened by treatment with either T40/A5 or T80/A5 3. discontinuation from the preceding 1235.5 trial because of any adverse event or any other reason 4. known or suspected secondary hypertension 5. mean seated SBP ≥ 180 mmHg and/or mean seated DBP ≥ 120 mmHg at any visit 6. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency) 7. severe renal impairment (e.g. serum creatinine > 3.0 mg/dl or > 265 µmol/L, known creatinine clearance < 30 mL/min or clinical markers of severe renal impairment)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of patients achieving diastolic blood pressure (DBP) control (defined as mean seated DBP < 90 mmHg at trough i.e. 24 hours after last dose) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward). |
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 |
up titration to T80/A5 if patients don't respond adequately (goal : DPB 90mmHg) under T40/A5. |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
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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see clinical trial protocol section 6.2.3 |
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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 | 3 |
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 | 3 |