EUCTR2005-004580-40-NL进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •(For full list, please see protocol)
- •- Outpatients 18 years of age and older.
- •- Male or female patients are eligible.
- •- 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.
- •- 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
- •(For full list, please see protocol)
- •- Pregnant or nursing (lactating) women,
- •- Women of child-bearing potential (WOCBP)
- •- Severe hypertension (msDBP = 110 mmHg and/or msSBP = 180 mmHg).
- •- History or evidence of a secondary form of hypertension.
- •- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •- 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.
- •- Current angina pectoris requiring pharmacological therapy.
- •- Second or third degree heart block without a pacemaker.
- •- Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any
- •symptomatic arrhythmia during the 12 months prior to Visit 1.
- •- Clinically significant valvular heart disease.
- •- Any medication, surgical or medical condition which might significantly alter the
- •absorption, distribution, metabolism, or excretion of study drugs 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
- •- 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 3 x 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 > 1.5 x ULN at Visit 1, a history of dialysis, or a history of
- •nephrotic syndrome.
- •- Current treatment with cholestyramine and colestipol resins.
- •- History of hypersensitivity to any of the study drugs or to drugs belonging to the
- •similar therapeutic class (ARB’s, ACE-I’s, thiazide diuretics, or other sulfonamide
- •derived drugs) as the study drugs.
- •- History of angioedema due to usage of an ACE-I or ARB.
- •- 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 of gouty arthritis
- •- 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.
- •- Patients who previously participated in a clinical trial that contained the trea
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