essential hypertension MedDRA version: 14.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Sponsors
Novartis Farmaceutica SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female outpatients age ? 18 years old 3. Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy). 4. Patients must have an office BP ? 140/90 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range 168
Exclusion criteria
Exclusion criteria: Patients with any of the following physiological states or concomitant medical conditions at Visit 1, Visit 2, Optional Visit 201 or Visit 3 will be excluded from participation in the study. 1. Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ?180 mmHg or msDBP ?110 mmHg) 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases 3. History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing?s disease, drug-induced hypertension, pheochromocytoma and polycystic kidney disease (PKD) 4. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneaous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease with in 6 months of Visit 1 5. Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 8% 6. Clinically significant valvular heart disease 7. Previous or current diagnosis of congestive heart failure NYHA Class II to IV 8. Second or third degree heart block without a pacemaker, potentially life threatening arrhythmia, symptomatic arrhythmia, or family history of torsade de pointe 9. Evidence of hepatic disease as determined by one of the following: ALT or AST values ? 3 x ULN at Visit 1, or a history of liver cirrhosis, hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 10. Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR 5.3 mmol/L at Visit 1 12. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of aliskiren, including but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1, regarded as clinically meaningful by the investigator 13. Patients with active gastritis, active peptic ulcer, gastro-esophageal reflux requiring medical therapy, gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator 14. Patients unwilling or unable to discontinue safely the use of current antihypertensive medications for a period up to 12 weeks, as required by the protocol. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1 and completing by Visit 2 15. History of drug or alcohol abuse within the last 1 year 16. History of angioedema, drug-related or otherwise 17. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of oral aliskiren 300 mg given once daily in reduction of mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of 8 week treatment under light meal (fed) versus fasted conditions in patients with mild to moderate hypertension.;Secondary Objective: To evaluate the efficacy of oral aliskiren 300 mg in reduction of mean 24 hour maDBP from baseline to end of 8 week treatment under light meal versus fasted conditions in patients with mild to moderate hypertension To evaluate the efficacy of oral aliskiren in reduction of the mean change of msSBP and msDBP To evaluate the effect of a light meal versus fasted condition on aliskiren pharmacokinetics and PRA To evaluate the proportion of patients achieving blood pressure control To assess the proportion of patients achieving a successful response in SBP reduction To evaluate the safety and tolerability of aliskiren under a light meal and fasted conditions in patients with mild to moderate hypertension;Primary end point(s): 24 hours mean systolic ambulatory blood pressure;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium, Canada, Italy, Slovakia, Spain, Taiwan, United States
Contacts
Public ContactInmaculada Bosch Tirau
Novartis Farmaceutica SA
Outcome results
None listed