E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with hypertension |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | M15 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020772 |
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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 |
To demonstrate the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that valsartan 160 mg/HCTZ 25 mg is significantly reducing the trough mean sitting diastolic blood pressure (MSDBP) after a 4-week treatment in the non-responder population. |
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E.2.2 | Secondary objectives of the trial |
To explore the efficacy of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis that: - valsartan 160 mg/HCTZ 25 mg is significantly reducing the trough mean sitting systolic blood pressure (MSSBP) after a 4-week treatment in the non-responder population, - valsartan 160 mg/HCTZ 25 mg is leading to higher normalization rate (defined as a MSDBP < 90 mmHg) and responder rate (defined as a MSDBP < 90 mmHg or 10 mmHg decrease compared to Visit 4) in the non-responder population after a 4-week treatment,
To explore the safety of valsartan 160 mg/HCTZ 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg by testing the hypothesis of comparable rates of adverse events and lab changes.
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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 patients >= 18 years 2. Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). 3. Patients with essential hypertension: - At Visit 1, untreated patients should have a MSDBP >= 100 mmHg and < 110 mmHg and treated patients need to have a MSDBP < 110 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit 1. This inclusion visit will be recorded as Visit 3 in the CRF. - At Visit 2, patients previously treated for hypertension need to have a MSDBP >= 100 mmHg and < 110 mmHg for entrance into the first treatment phase. Patients previously treated for hypertension who have a MSDBP < 100 mmHg at Visit 2 will continue the wash-out phase and will be again evaluated with regard to BP criteria at Visit 3. Untreated patients do not perform Visit 2. - At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have a MSDBP >= 100 mmHg and < 110 mmHg for entrance into the first treatment phase. - At Visit 4, all patients need to have a MSDBP >= 90 mmHg for entrance into the second treatment phase 4. Written informed consent to participate in the study prior to any study procedures
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E.4 | Principal exclusion criteria |
1. MSDBP >= 110 mmHg or MSSBP >= 180 mmHg 2. Pregnant or nursing women 3. Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg) 4. History of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months 5. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis or pheochromocytoma 6. Known or suspected contraindications including history of allergy to angiotensin II receptor blockers or to diuretics as described in the basic product information (particularly olmesartan medoxomil 20 mg or 40 mg, valsartan 160 mg) 7. Heart failure NYHA II-IV 8. Concomitant refractory angina pectoris, potentially life-threatening arrhythmia or symptomatic arrhythmia or clinically significant valvular heart disease 9. Transient ischemic cerebral attack, stroke or myocardial infarction during the last 12 months prior to Visit 1 10. Type 1 diabetes mellitus or poorly controlled Type 2 DM 11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 12. Patient with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exists, are excluded, with the exception of localized basal cell carcinoma of the skin 13. Participation in any investigational drug trial within one month prior to Visit 1
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter of this trial is the change in trough MSDBP between Visit 4 (olmesartan medoxomil 40 mg or olmesartan medoxomil 20 mg plus HCTZ 12.5 mg) and Visit 5 (valsartan 160 mg/HCTZ 25 mg). |
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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 | 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 | No |
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 |
sequential non-responder trial |
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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.8.5 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |