E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage II arterial Hypertension |
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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 assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: Lowering blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure
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E.2.2 | Secondary objectives of the trial |
To assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: Lowering blood pressure at week 12 Percentage of control at week 12
To assess if inicial and titration therapy with a combined fixed dose ise superior to inicial and titration monotherapy in stage II hipertensión on: quality of life patient´s adherence secondary effects Lowering blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients diagnosed of stage II arterial hipertensión (JNC7, BP>160/100), currently without therapy, or under monotherapy al teast 4 weeks who have not reaches BP control. 2. For diabetic patients BP to be included will be >150/90. 3. White coat hypertension has been excluded (Ambulatory BP Monitorization) 4. Informed consent.
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E.4 | Principal exclusion criteria |
1. Patient denies to participate. 2. Patient is not an adult, of has not a mental condition to understannd protocol procedures and collaborate. 3. Non complaints. 4. Alcohol or drug abuse. 5. Pregnant women or breastfeeding period, or women who foresee to become pregnant 6. Secondary hypertension (suspected or confirmed) 7. White coat hypertension 8. Combined therapy is needed due to patient´s clinical condition. 9. Presence of cardiovascular disease. 10. Renal damage (Creatinine > 1,2 (women) y 1,5 (men)). 11. Liver disease (serum transaminases > 3 times upper limit, or chronic liver disease). 12. High serum potassium (>5,5) 13. Severe current disease (cancer, degenerative..) 14. Patients currently treated and controlled 15. Patients not controlled under combination theraphy. 16. Very high BP (>200/110) 17. Intolerance, allergy or contraindication to study medication (ARB and diuretics)
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E.5 End points |
E.5.1 | Primary end point(s) |
Blood pressure at week 24 Percentage of control at week 24 Time from begining of treatment to control of blood pressure |
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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 | No |
E.6.5 | Efficacy | No |
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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |