A six-week, randomized, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of the combination of aliskiren 150 mg and amlodipine 5 mg compared to amlodipine 5 mg and 10 mg in hypertensive patients not adequately responsive to amlodipine 5 mg
- Conditions
- Hypertension
- Registration Number
- EUCTR2004-002410-11-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 566
•Outpatients 18 years of age and older.
•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.
•Patients with essential hypertension.
•Non-treated patients must have a MSDBP = 95 mmHg and <110 mmHg.
•Treated patients must have MSDBP < 110 mmHg.
•To be eligible for single-blind treatment at Visit 2 (Day -28) all patients must have a MSDBP = 95 mmHg and < 110 mmHg and to be eligible for randomization at Visit 4 (Day 1), all patients must have a MSDBP = 90 mmHg and < 110 mmHg.
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
•Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
•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.
•History of hypertensive encephalopathy or cerebrovascular accident.
•Transient ischemic cerebral attack during the 12 months prior to Visit 1.
•Current diagnosis of heart failure (NYHA Class II-IV).
•History of myocardial infarction.
•History of coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
•Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates).
•Second or third degree heart block without a pacemaker.
•Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
•Clinically significant valvular heart disease or severe aortic stenosis.
•Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9% at Visit 1.
•Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L or = 5.5 mEq/L, or dehydration at Visit 1.
•Any surgical or medical condition or treatment that 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 or SGPT 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 for women and serum creatinine > 2.0 mg/dl for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
•Current treatment with cholestyramine and colestipol resins.
•History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
•History or evidence of drug or alcohol abuse within the last 12 months.
•Pregnant or nursing women.
•Known or suspected contraindications to the study medications, including history of allergy to amlodipine or dihydropyridine like calcium channel blockers.
•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.
•Participation in any investigational drug trial within one month of Visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method