An 8-week, randomized, double-blind, parallel-group, multicenter study assessing the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in patients = 65 years of age with essential hypertension, using 24-hour ABPM with lisinopril 10 mg as a reference
- Conditions
- Hypertension
- Registration Number
- EUCTR2004-004255-18-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
•Outpatients = 65 years of age and older.
•Male or female patients are eligible.
•Patients with essential hypertension. Patients must have an office cuff MSSBP = 140 mmHg and <180 mmHg at Visit 2 or Visit 201 and an office cuff MSSBP = 145 mmHg and < 180 mmHg at Visit 3. Patients must also have a baseline mean 24 hour systolic ABPM >135 mmHg at Visit 3.
•Patients must have an absolute difference of ? 10 mmHg in their mean office cuff sitting systolic blood pressure (MSSBP) during the last two visits (Visit 2 and 3 or the optional Visit 201 and 3) of the single-blind placebo run-in period of the study.
•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) no
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 with any of the following physiological states or concomitant medical conditions at either Visit 1, Visit 2, optional visit 201 or Visit 3 (unless otherwise stated) will be excluded from participation in the study.
•Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
•Severe hypertension ( Office MSDBP = 110 mmHg and/or Office 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 or previous diagnosis of heart failure (NYHA Class II-IV).
•History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
•Current angina pectoris requiring pharmacological therapy
•Second or third degree heart block without a pacemaker.
•Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
•Clinically significant valvular heart disease.
•Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
•Patients employed as a night shift worker.
•Arm circumference <24 cm OR > 42 cm.
•A diagnosis of Atrial Fibrillation
•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 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 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 > 1.5 X ULN at Visit 1 [ULN: male = 1.3 mg/dL (115 umol/L), female = 1.2 mg/dL (106 umol/l)], a history of dialysis, or a history of nephrotic syndrome.
•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.
•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.
•History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
•Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
•Participation in any investigational drug trial within one month of Visit 1.
•Persons directly involved in the executio
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