A 54-week, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg / valsartan 320 mg in patients with essential hypertension. - SPV2301

ovartis0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

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•1. Outpatients 18 years of age and older.
•2. Male or female patients are eligible.
•3. For newly diagnosed/untreated patients with essential hypertension defined as DBP > 90 and < 110 mmHg at Visit 1 and Visit 2.
•4. 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).

•1. Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg)
•2. History or evidence of a secondary form of hypertension
•3. 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).
•4. Previous or current diagnosis of heart failure (NYHA Class III-IV).
•5. 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.
•6. Current angina pectoris requiring pharmacological therapy except for nitrates.
•7. Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1

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