E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate 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 demonstrate the blood pressure reduction effect of valsartan/HCTZ 320/25 mg o.d. or 320/12.5 mg o.d. in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy o.d. (MSDBP ≥90 mmHg and 110 mmHg at Visit 3) by testing the hypothesis that either valsartan/HCTZ 320/25 mg o.d. or valsartan/HCTZ 320/12.5 mg o.d. produces superior reduction in the mean sitting diastolic blood pressure (MSDPB) from baseline compared to valsartan 320 mg o.d alone |
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E.2.2 | Secondary objectives of the trial |
1. Diastolic blood pressure reduction of valsartan/HCTZ 320/25 mg o.d. vs 320/12.5 mg o.d. in patients not adequately controlled with valsartan 320 mg monotherapy o.d. ( MSDBP ≥90 mmHg and 110 mmHg at Visit 3) 2. Systolic BP reduction by valsartan/HCTZ 320/25 mg or valsartan/HCTZ 320/12.5 mg, in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy 3. efficacy of valsartan/HCTZ 320/25 mg compared to 320/12.5 mg, in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy, by testing the hypothesis that the combination of valsartan/HCTZ 320/25 mg produces superior reductions in MSSBP compared to the combination of valsartan/HCTZ 320/12.5 mg; 4. responder rates at the end of the study of these three treatments 5.relative tolerability and safety
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female outpatients age between 18-80 years of age, inclusive 2. Diagnosed at enrollment (Visit 2) to be mild to moderate hypertensive with a MSDBP 95 and <110 mmHg for non treated patients. Previously treated patients should have a MSDBP <110 mmHg at Visit 1 and a MSDBP 95 and <110 mmHg at Visit 2. 3. At Visit 3 all patients must have a MSDBP 90 mmHg and 110 mmHg.. 4. Written informed consent to participate in the study prior to any study procedures 5. Ability to communicate and comply with all study requirements
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E.4 | Principal exclusion criteria |
1. Severe hypertension ( MSDBP 110 mmHg and/or MSSBP 180 mmHg ). 2. Inability to discontinue all prior anti-hypertensive medications safely for a period of 2-4 weeks, as required by the protocol. 3. Female patients who are not either post-menopausal for one year or surgically sterile, or who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Hormonal contraceptive use is disallowed. 4. History of hypertensive encephalopathy or cerebrovascular accident within 1 year prior to Visit 1. 5. Known Keith-Wagener grade III or IV hypertensive retinopathy. 6. Transient ischemic cerebral attack, myocardial infarction, all types of revascularization procedures during the last 12 months prior to Visit 1. 7. Heart failure requiring treatment. 8. Second or third degree heart block without a pacemaker. 9. Concomitant refractory angina pectoris. 10. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia or 11. Clinically significant valvular heart disease. 12. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, etc. 13. Diabetes patients requiring insulin treatment 14. Type 2 diabetic patients who, in the opinion of the investigator, are not well controlled. 15. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is the change from baseline in trough mean sitting diastolic blooding pressure (MSDBP) at the endpoint. MSDBP is defined as the average of available readings of the sitting diastolic blood pressure from one visit. If all three readings are missing at a particular visit, MSDBP will not be calculated. However, for the endpoint, the last post-baseline measurement during the double-blind period will be carried forward as the endpoint measurement. |
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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 | No |
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 | 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 | 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 | 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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |