EUCTR2006-002621-23-DE进行中（未招募）不适用
A 54-week, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300mg/ valsartan 320 mg in patients with essential hypertension.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 834
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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
- •- 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
- •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 secti
研究者
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