A study conducted in several countries and centres to compare the efficacy and safety of an 8 week treatment of patients with high blood pressure with aliskiren 300mg given once daily in fasted state compared to fed state

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 568

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 < 180/110 mmHg at the randomization visit and the preceding visit
5.Patients must have an absolute difference of = 10 mmHg in both their msSBP and in their msDBP between the randomization visit and the preceding visit
6.Ability to communicate and comply with all study requirements

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 388
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

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 < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome
11.Other significant laboratory findings such as anemia defined as Hb < 10 g/dL, serum sodium value < 132 mmol/L or serum potassium values <3.5 mmol/L or >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 enroll

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

Related Trials