essential hypertension MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Amlobesilat-Sandoz Tabletten
Pharmaceutical Form: Tablet
CAS Number: 111470-99-6
Other descriptive name: AMLODIPINE BESILATE
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with controlled blood pressure levels (msSBP 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 4 weeks of treatment with SPC Aliskiren 300 mg / Amlodipine 10 mg at Visit 6 provide additional mean sitting diastolic blood pressure reduction in hypertensive patients not adequately responding (i.e., msDBP = 90 mmHg) to 4 weeks of treatment with an Angiotensin-receptor blocker plus Amlodipine 10 mg in SPC (Olmesartan 40 mg / Amlodipine 10 mg) at Visit 5. ;Secondary Objective: To evaluate the effects of 4 weeks of treatment with SPC Aliskiren 300 mg / Amlodipine 10 mg at Visit 6 in patients not adequately responding (i.e., msDBP = 90 mmHg) to 4 weeks of treatment with an Angiotensin-receptor blocker plus Amlodipine 10 mg in SPC (Olmesartan 40 mg / Amlodipine 10 mg) on the difference in mean sitting systolic blood pressure, pulse pressure, heart rate, normalization, control and responder rate at Visit 5 (s. Section 7.4). To assess the safety and tolerability of Aliskiren 300 mg / Amlodipine 10 mg. ;Primary end point(s): The aim of this multicenter open-label trial is to evaluate the reduction in trough msDBP by a 4-week treatment with the single pill combination of Aliskiren 300 mg / Amlodipine 10 mg SPC in hypertensive patients not adequately controlled by Olmesartan 40 mg in SPC combination with Amlodipine 10 mg. The main interest is the estimation and testing of the changes in BP between Visit 5 and Visit 6. | — |
Countries
Germany
Outcome results
None listed