An open-label, multicenter study to evaluate the efficacy and safety of a 4 week therapy with the single pill (SPC) combination of Aliskiren 300 mg / Amlodipine 10 mg in hypertensive patients not adequately respond to an uptitrated 4 week therapy with the SPC of Olmesartan 40 mg / Amlodipine 10 mg, with a potential extention if patients still not adequately respond with a 4 week therapy with the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg - AWESOME
- Conditions
- essential hypertensionMedDRA version: 12.1Level: LLTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2009-016693-33-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Male or female patients ? 18 years
2.Patients with essential hypertension:
-At Visit 1, untreated (never been treated with antihypertensives or in the last 4 weeks not been treated with antihypertensives) patients must have an msDBP ? 100 mmHg and < 110 mmHg and msSBP ? 160 and < 180 mmHg and treated patients need to have an msDBP < 110 mmHg and msSBP < 180 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit 1. This inclusion visit will be recorded as Visit 3 in the CRF.
-At Visit 2, patients previously treated for hypertension need to have an msDBP ? 100 mmHg and < 110 and msSBP ? 160 and < 180 mmHg for entry into the first treatment phase. Patients previously treated for hypertension who have an msDBP < 100 mmHg and/or msSBP < 160 mmHg at Visit 2 will continue the wash-out phase and will be again evaluated with regard to BP criteria at Visit 3. Untreated patients do not perform Visit 2.
-At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have an msDBP ? 100 mmHg and < 110 mmHg and msSBP ? 160 and < 180 mmHg for entry into the first treatment phase.
-At Visit 5, all patients need to have an msDBP ? 90 mmHg for entry into the second treatment phase
3.Written informed consent to participate in the study prior to any study procedures
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 with controlled blood pressure levels (msSBP < 140 mmHg and msDBP < 90 mmHg) under current antihypertensive therapy at Visit 1.
2.msDBP ? 110 mmHg or msSBP ? 180 mmHg at any time between Visit 1 and baseline
3.Inability to completely discontinue all antihypertensive medications safely for a period of up to 2 weeks, as required by the protocol
4.Known Keith-Wagener grade III or IV hypertensive retinopathy
5.Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis or pheochromocytoma
6.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to angiotensin II receptor blockers, direct renin inhibitors or to calcium channel blockers as described in the SmPC (particularly Olmesartan 10-40 mg, Amlodipine 5-10 mg, Aliskiren 300 mg)
7.Concurrent treatment with cyclosporine or quinidine or verapamile at Visit 1 or during the trial
8.History of angiooedema due to Aliskiren treatment.
9.Bilateral renal artery stenosis
10.Heart failure NYHA II-IV
11.Second or third degree heart block without pacemaker
12.Current angina pectoris requiring pharmacological therapy
13.Concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
14.Clinically significant valvular heart disease
15.Transient ischemic cerebral attack, stroke, hypertensive encephalopathy or myocardial infarction prior to Visit 1
16.Type 1 diabetes mellitus
17.Type 2 diabetes mellitus with poor glucose control as defined by persistent fasting blood glucose > 11 mmol/l or > 200 mg/dl at Visit 1.
18.Advanced aortic stenosis
19.Shock and cardiogenic shock
20.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following:
?History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
?Currently active inflammatory bowel syndrome within 12 months prior to Visit 1
?Currently active gastritis, ulcers or gastrointestinal/ rectal bleeding (hemorrhoids not included)
?Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/ injury
?Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT or AST values > 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt, obstruction of the biliary tract
?Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 x ULN or active acute glomerulonephritis at Visit 1, a history of dialysis, or a history of nephrotic syndrome
?Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
21.Therapy resistant hypokalemia, hypercalcemia, symptomatic hyperuricemia or sodium depletion (< 134 mmol/l), patients with volume depletion.
22.History of any severe, life-threatening disease
23.History of drug or alcohol abuse within the last 2 years
24.History of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol.
25.Any condition, which in the judgment of the investigator or medical monitor, would
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