An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren/HCTZ (150/25 mg and 300/25 mg) in comparison with HCTZ 25 mg in patients with essential hypertension not adequately responsive to HCTZ 25 mg monotherapy - Phase III study in hypertensive patients non reponder on HCTZ

ovartis0 个研究点目标入组 70 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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•For full list, see protocol;Patients with a diagnosis of hypertension:;Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP * 95 mmHg and < 110 mmHg at Visit 1.;All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP * 85 mmHg and < 110 mmHg at Visit 2.;All patients must have a msDBP * 90 mmHg and < 110 mmHg at Visit 5.

•For full list, see protocol;Severe hypertension (msDBP * 110 mmHg and/or msSBP * 180 mmHg).;History or evidence of a secondary form of hypertension.;Previous or current diagnosis of heart failure.;History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).;Serum potassium < 3.5 mEq/L (mmol/L) or * 5.3 mEq/L (mmol/L), serum sodium less than the lower limit of normal or dehydration.;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 oral antidiabetic medication for at least 4 weeks prior to Visit 1.;Patients who previously enrolled in the active drug treatment period of a clinical trial that contained the treatment combination of aliskiren/HCTZ.

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