essential hypertension MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Trade Name: Exforge 10 mg/160 mg Filmtabletten
Product Name: Exforge 10mg/160mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Amlodipine
CAS Number: 111470-99-6
Concentrat
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 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. 15. 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, or 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 16. Therapy resistant hypokalemia, hypercalcemia, symptomatic hyperuricemia or sodium depletion (< 134 mmol/l), patients with volume depletion. 17. History of any severe, life-threatening disease 18. History of drug or alcohol abuse within the last 2 years 19. History of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol. 20. Any condition, which in the judgment of the investigator or medical monitor, would jeopardize the evaluation of efficacy or safety 21. Any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 4 weeks of treatment with amlodipine 10 mg plus valsartan 160 mg in fixed dose combination provide an additional mean sitting diastolic blood pressure reduction 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 free combination (olmesartan 20 mg plus amlodipine 10 mg). ;Secondary Objective: To evaluate the effects of 4 weeks of treatment with amlodipine 10 mg / valsartan 160 mg in fixed dose combination 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 free combination (olmesartan 20 mg plus amlodipine 10 mg) on mean sitting systolic blood pressure, pulse pressure, heart rate, normalization and responder rate. To assess the safety and tolerability of amlodipine 10 mg / valsartan 160 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 fixed dose combination of amlodipine 10 mg and valsartan 160 mg in hypertensive patients not adequately controlled by olmesartan 20 mg in free combination with amlodipine 10 mg. The main interest is the estimation and testing of the changes in BP between Visit 4 and Visit 5. | — |
Countries
Germany
Outcome results
None listed