E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg/ valsartan 320 mg in patients with essential hypertension (msDBP > 90 mmHg and < 110 mmHg. |
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E.2.2 | Secondary objectives of the trial |
- To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/valsartan in patients with essential hypertension (msDBP > 90 mmHg and <110 mmHg) - To evaluate the proportion of patients achieving the blood pressure control target of < 140/90 mmHg at the end of study.
Exploratory objective(s) 1. To explore the effect of long-term treatment with the combination of aliskiren 300 mg/valsartan 320 mg on plasma renin activity (PRA), plasma aldosterone and plasma renin concentration (PRC). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Outpatients 18 years of age and older. - Male or female patients are eligible. - For newly diagnosed/untreated patients with essential hypertension defined as DBP > 90 and <110 mmHg at Visit 1 and Visit 2. - For previously treated patients with essential hypertension defined as DBP > 90 and < 110 mmHg after 2 to 4 weeks of washout (Visits 3 or 4). - Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). |
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E.4 | Principal exclusion criteria |
- Previously treated in an aliskiren study that contained the treatment group of the combination of aliskiren and valsartan and had been randomized or enrolled into the active drug treatment period of that study. - Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg) - Pregnant or nursing (lactating) women - Women of child-bearing potential (WOCBP) - History or evidence of a secondary form of hypertension - Any history of hypertensive encephalopathy or cerebrovascular accident, or history within 12 months from visit 1 for transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). - Previous or current diagnosis of heart failure (NYHA Class III –IV) - Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1. - Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator's clinical judgment. Patients with diabetes mellitus enrolled in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of antidiabetic medication for at least 4 weeks prior Visit 1. - Current angina pectoris requiring pharmacological therapy except for nitrates. - Second or third degree heart block without a pacemaker. - Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1. - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. • History of active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or history of gastrointestinal bleeding during the 3 months prior to Visit 1. • Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt. • Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine or colestipol resins. - History of hypersensitivity to any of the medications or drugs belonging to the similar therapeutic class (ARB's, ACE-I, thiazide diuretics, or other sulfonamide derived drugs) as the study drugs. - 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. - History or evidence of drug or alcohol abuse within the last 12 months. - Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer. - If subject is expected to continue or start any medication listed in section 6.6.5 concomitant medication. - History of noncompliance to medical regimens or unwillingness to comply with the study protocol. - Any condition which in the opinion of the investigator or the Novartis Medical Monitor would confound the evaluation and interpretation of efficacy and/or safety. - Persons directly involved in the execution of this protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 | 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 | 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 | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | 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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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 years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 2 |