A 36 week, randomized, double-blind, multi-center, parallel group study comparing the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of left ventricular hypertrophy in overweight patients with essential hypertensio
- Conditions
- Hypertension
- Registration Number
- EUCTR2005-000856-34-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
1.Outpatients 18 to 80 years of age.
2.Male and female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile or using effective method of spermicide, or using an intrauterine device.
3.Patients with a history of essential hypertension.
4.Patients newly diagnosed with essential hypertension with a BP (MSDBP = 90 mmHg and < 110 mmHg and MSSBP = 140 mmHg and < 180 mmHg) at the Study Visit 3.
5.Patients with a BMI > 25 kg/m2.
6.Patients with LVH (LVWT = 1.3 cm) confirmed by the ECHO core laboratory prior to Study Visit 3.
7.Patients who are eligible, 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
1.Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
2.Patients treated with an ACE and ARB combination at study entry (Study Visit 1).
3.Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
4.Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e., idiopathic or valvular). Hemodynamically significant mitral stenosis or lesions of the left ventricular outflow tract including aortic stenosis or hypertrophic obstructive cardiomyopathy.
5.Severe refractory hypertension defined as MSSBP = 180 mmHg and/or MSDBP = 110 mmHg) at Study Visit 1.
6.Patients currently under treatment with disallowed medications (including antihypertensive agents given for other indications e.g. beta blockers being given for ischemic heart disease) which in the opinion of the investigator cannot be discontinued prior to entry in the study.
7.Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy (e.g., Chagas’ disease).
8.History of symptomatic heart failure (NYHA classes II-IV) or a LVEF = 40% confirmed by the ECHO core laboratory prior to Study Visit 3.
9.Myocardial infarction or coronary revascularization (CABG or PCI), within 6 months of Study Visit 1.
10.Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1.
11.Serum potassium = 5.2 mEq/L, or dehydration at Study Visit 1.
12.Use of pacemakers, ICD, defibrillators or any device which interferes with an MRI.
13.Patients with non-sinus rhythm or frequent extrasystoles (>6/min).
14.Patients who cannot lie supine for at least 30 minutes.
15.Patients who cannot hold their breath for 15 seconds.
16.Presence of cranial aneurysm clips, ocular metallic shards, or coronary artery metal stents.
17.Patients whose body structure (e.g., weight, height, body circumference, etc.) exceeds the restrictions of the local site MRI instrument.
18.Patients who are morbidly obese with a BMI = 42 kg/m2.
19.Significant claustrophobia (not responsive to light intravenous anxiolytics).
20.Patients employed as a night shift worker.
21.Arm circumference = 50 cm.
22.Current abuse or recent history of alcohol or other drug substance abuse (past 12 months).
23.Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy < 1 year).
24.Patients considering undergoing elective gastric bypass surgery, or any other bariatric surgical procedures at any time after Study Visit 1.
25.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs (for list see protocol)
26.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.
27.History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
28.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
29.Persons directly involved in the execution of this protocol.
30.Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled int
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