left ventricular hypertrophy in overweight patients with essential hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Tablet
INN or Proposed INN: aliskiren
CAS Number: 173334-58-2
Current Sponsor code: SPP100
Other descriptive name: none
Concentration
Sponsors
Novartis Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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 Study Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Study 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 Study Visit 1, a history of hepatic enc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the superior efficacy of the combination of aliskiren 300 mg and losartan 100 mg by testing the hypothesis of regression of left ventricular hypertrophy, as measured by the change in LVMI from baseline to end of study using MRI, when compared to losartan 100 mg.;Secondary Objective: • Evaluate the efficacy of aliskiren 300 mg compared to losartan 100 mg on the regression of left ventricular hypertrophy, as measured by the change in LVMI from baseline to end of study using MRI. • Evaluate the efficacy of the combination of aliskiren 300 mg and losartan 100 mg compared to losartan 100 mg on the change in LVH parameters from baseline to the end of study as assessed by MRI. • Evaluate the effect of aliskiren 300 mg compared to losartan 100 mg on the change in LVH parameters from baseline to the end of study, as assessed by MRI. • Evaluate the effect of the combination of aliskiren 300 mg and losartan 100 mg compared to each of the component monotherapies on the change in LVH parameters from baseline to the end of study, as assessed by centrally read ECG. • Evaluate the effect of aliskiren 300 mg compared to losartan 100 mg on the change in LVH parameters from baseline to the end of study, as assessed by centrally read ECG. • ;Primary end point(s): The primary analysis will be change from baseline (Study Visit 3) in left ventricular mass index (LVMI) as measured by MRI at end of study (Study Visit 11 or MRI measurement at = 28 weeks into the double blind period for patients who discontinue) will be used to compute change from baseline in LVMI. | — |
Countries
Finland, Germany, Italy, Spain, Sweden
Outcome results
None listed