| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 efficacy of a valsartan treatment strategy compared to an amlodipine treatment strategy by testing the hypothesis of non-inferiority in reaching blood pressure control at end of study (Visit 6, week 14) as determined by proportion of patients that are controlled
If this can be demonstrated, superiority will be tested between the valsartan treatment strategy group and the amlodipine treatment strategy group. |
|
| E.2.2 | Secondary objectives of the trial |
-Efficacy of a valsartan strategy compared to an amlodipine strategy, for the whole study population, by testing non-inferiority in reaching BP control at week 4, 8, and 11. If this can be demonstrated, superiority will be tested
- Efficacy, in each of the two patient strata, (treatment naïve and previously treated and uncontrolled on present monotherapy), of a valsartan strategy compared to an amlodipine strategy by testing non-inferiority in reaching BP control at week 4, 8, 11 and 14 If this can be demonstrated, superiority will be tested.
- Time to BP control of the valsartan versus amlodipine treatment strategy in the overall population and in the two strata
- MSSBP and MSDBP lowering of the valsartan versus amlodipine strategy in the overall population and in the two strata between baseline and week 4, 8, 11 and 14
- Safety and tolerability of the valsartan versus amlodipine strategy in the overall population and in the two strata between baseline and end of study |
|
| 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- 75 years of age, inclusive, at Visit 1
2. Stage/grade 1 or stage/grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/or MSDBP ≥ 90 mm Hg, (based on the JNC-VII/ESC/ESH guidelines), at Visit 1 and 2 in untreated patients Untreated is defined as treatment naïve or patients not treated in the past 12 weeks.
Or
Patients who are currently treated on monotherapy and uncontrolled (i.e. MSSBP ≥
140 mm Hg, and/or MSDBP ≥ 90) and have a blood pressure ≤ 160/100 mmHg at Visit 1 and Visit 2. Treatment is defined as having taken medication for a minimum of 4 weeks and until ≤ 2 days prior to Visit 1.
Patients who neither meet the definition of treated or untreated will not be eligible for study entry.
3. Written informed consent to participate in the study prior to any study procedures |
|
| E.4 | Principal exclusion criteria |
1. Current treatment with a CCB
2. MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between Visit 1 and Visit 2
3. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
4. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma, etc.
5. Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1
6. Transient ischemic cerebral attack during the last 6 months, prior to Visit 1
7. History of/or symptoms consistent with congestive heart failure
8. Clinically significant valvular heart disease
9. Second or third degree heart block without a pacemaker
10. Concomitant angina pectoris
11. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
12. Diabetes mellitus
13. Serum potassium < 3.5 or > 5.5 mmol/L without medication at Visit 1
14. Serum creatinine > 1.5 ULN at Visit 1 or a history of dialysis or nephrotic syndrome
15. ALT or AST values > 2 x ULN at Visit 1 or a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) at Visit 1
17. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
18. Any surgical or medical condition which might alter the absorption, distribution,
metabolism, or excretion of any drug
19. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
20. History of any severe or life- threatening disease
21. History of drug or alcohol abuse within the last two years
22. History of noncompliance to medical regimens, or patients unwilling to comply with the study protocol
23. Any condition in the investigators opinion, which renders the patient unable to complete the study or which would produce significant risk to the patient
24. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer
25. Persons directly involved with the conduct of this study
26. Inability to communicate and comply with all study requirements |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at week 14. |
|
| 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) | 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 | 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 |
|
| 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
| |
| 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 | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
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