Patients with essential hypertension MedDRA version: M15 Level: LLT Classification code 10015488
Conditions
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 (not having been treated with antihypertensive drugs in the month priot to V1) need to have a MSSBP >= 160 mmHg and = 160 mmHg and = 160 mmHg and = 140 mmHg for entrance 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
Exclusion criteria
Exclusion criteria: 1. MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at any time between Visit 1 and Baseline 2. Inability to discontinue all antihypertensive medications safely for a period of up to two weeks prior to initiation of treatment 3. History of hypersensitivity to valsartan, ramipril, felodipine, amlodipine, inactive ingredients of these study drugs or to drugs with similar chemical structure, history of angioneurotic oedema 4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease 5. Known Keith-Wagener grade III or IV hypertensive retinopathy 6. Second or third degree heart block without a pacemaker, concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, clinically significant valvular heart disease 7. Heart failure NYHA II -IV 8. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, Cushing’s disease, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease 9. Diabetes mellitus type I or 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. 10. Evidence of hepatic disease as determined by AST (SGOT) or ALT (SGPT) values > 2 x ULN at Visit 1 11. Known bilateral kidney artery stenosis or unilateral stenosis of the kidney artery if patient has only a single kidney 12. Patients after kidney transplantation 13. Known hypertrophic obstructive cardiomyopathy 14. Known primary hyperaldosteronism 15. A history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 16. Evidence of renal impairment as determined by one of the followings: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. If creatinine is found to be between 1.5 and 2 x UNL, a retest can be performed prior to initiation of treatment 17. Any severe, life-threatening disease within the past five years 18. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 19. Any surgical or medical condition which, at the discretion of the investigator, places 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 the study or completing the trial period 20. History of drug or alcohol abuse within the last 2 years 21. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives before enrollment, whichever is longer 22. History of noncompliance with medical regimens, or patients unwilling to comply with the study protocol 23. Persons directly involved in the execution of this protocol/study 24. Inability to communicate and comply with all study requirements 25. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 26. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml). 27. Women of child-bearing potential (WOCBP), defined as all women physiolo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 5 weeks of treatment with valsartan 160 mg plus amlodipine 10 mg provide an additional mean sitting systolic blood pressure reduction in patients not adequately responding to 5 weeks of treatment with ramipril 5 mg and felodipine 5 mg (i.e., MSSBP = 140 mmHg). ;Secondary Objective: To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic blood pressure, normalization and responder rate. To assess the safety and tolerability of valsartan 160 mg plus amlodipine 10 mg. ;Primary end point(s): The primary efficacy parameter of this trial is the change in trough MSSBP between Visit 4 (ramipril 5 mg plus felodipine 5 mg) and Visit 5 (valsartan 160 mg plus amlodipine 10 mg). The mean change will be calculated and tested against the null hypothesis of no change using a one-sample t-test. Point estimates, p-values and (95%) confidence intervals will be reported. The two-sided significance level is set to 5% The primary analysis will be performed using the ITT-population | — |
Countries
Germany
Outcome results
None listed