EUCTR2004-001061-17-ES进行中（未招募）不适用
A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing aliskiren to ramipril with optional addition of hydrochlorothiazide (HCTZ), followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertension
ovartis Farmacéutica S.A0 个研究点目标入组 846 人开始时间: 2006年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 846
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
- •1. Outpatients 18 years of age and older.
- •2. Patients with essential hypertension. Patients must have MSDBP = 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3 (i.e. Visit 2 or Optional Visit 201).
- •3. Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
- •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).
- •To be eligible for randomization into the double-blind active-controlled treatment period at Visit 3, patients must fulfill the following criteria:
- •5. Patients must have a MSDBP ? 95 mmHg and < 110 mmHg at Visit 3 (Day 1).
- •6. Patients must have an absolute difference of ? 10 mmHg in their mean sitting diastolic blood pressure (MSDBP) between Visit 3 and the visit immediately prior to Visit 3 (i.e., Visit 2 or optional Visit 201).
- •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
- •1. Patients who previously enrolled in an aliskiren study and who qualified to be randomized into the active drug treatment period.
- •2. Severe hypertension (grade 3 WHO classification; MSDBP ? 110 mmHg and/or MSSBP ? 180 mmHg).
- •3. History or evidence of a secondary form of hypertension.
- •4. Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •5. History of hypertensive encephalopathy or cerebrovascular accident
- •6. Transient ischemic cerebral attack within 12 months prior to Visit 1.
- •7. Current diagnosis of heart failure (NYHA Class II-IV).
- •8. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Visit 1.
- •9. Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates).
- •10. Second or third degree heart block without a pacemaker.
- •11. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •12. Clinically significant valvular heart disease.
- •13. Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 9% at Visit 1.
- •14. Serum sodium less then the lower limit of normal, serum potassium less than 3.5 mEq/L or = 5.2 mEq/L, or dehydration at Visit 1.
- •15. Any 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
- •Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1
- •Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- •Evidence of hepatic disease as determined by any one of the following: SGOT/AST or SGPT/ALT 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 > 1.7 mg/dL (corresponding to 150 ?mol/L) for women and serum creatinine > 2.0 mg/dL (corresponding to 177 ?mol/L) for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome
- •Current treatment with cholestyramine or cholestipol resins
- •16. History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years.
- •17. History or evidence of drug or alcohol abuse within the last 12 months.
- •18. Pregnant or nursing women.
- •19. 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.
- •20. Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drugs.
- •21. History of gouty arthritis.
- •22. History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •23. Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
- •24. Participation in any
研究者
相似试验
进行中（未招募）
不适用
A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing aliskiren to ramipril with optional addition of hydrochlorothiazide (HCTZ), followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertensioHypertensionEUCTR2004-001061-17-DKovartis Pharma Services AG846
进行中（未招募）
不适用
A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing aliskiren to ramipril with optional addition of hydrochlorothiazide (HCTZ), followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertensioHypertensionEUCTR2004-001061-17-BEovartis Pharma Services AG846
进行中（未招募）
1 期
A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing aliskiren to ramipril with optional addition of hydrochlorothiazide (HCTZ), followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertensioHypertensionEUCTR2004-001061-17-SKovartis Pharma Services AG846
进行中（未招募）
1 期
A 26 week, double-blind, randomized, multicenter, parallel group, active-controlled study comparing aliskiren to ramipril with optional addition of hydrochlorothiazide (HCTZ), followed by a 4 week double-blind, randomized, placebo-controlled withdrawal in patients with essential hypertensioHypertensionEUCTR2004-001061-17-ISovartis Pharma Services AG846
进行中（未招募）
不适用
A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phaseEUCTR2008-007015-32-DEovartis Pharma GmbH