Hypertension
Conditions
Interventions
Product Name: Valsartan
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Valsartan
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to discontinue all prior antihypertensive medications safely for a period of 1 to 5 weeks as required by the protocol. 2. Patients with an MSSBP = 180 mmHg and MSDBP 5 mIU/ml). 7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. • Hormonal contraceptive use is disallowed. 8. Known moderate or malignant retinopathy. Defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk). 9. Any history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. 10. Any history of myocardial infarction or all types of revascularization procedures. 11. Heart failure requiring treatment. 12. Second or third degree heart block with or without a pacemaker. 13. Angina pectoris of any type. 14. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 15. Clinically significant valvular heart disease. 16. Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease. 17. All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who are not well controlled based on the Investigator’s clinical judgement. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1. 18. Any condition, not identified in the protocol, that in the opinion of the Investigator or the Novartis monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the trial period. 19. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that at least one of the following two effciacy criteria is met. • A once daily dosing regimen of the triple combination of valsartan/HCTZ/amlodipine is superior to the dual combinations of valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in lowering mean sitting diastolic blood pressure (MSDBP) in patients with moderate to severe hypertension. • A once daily dosing regimen of the triple combination of valsartan/HCTZ/amlodipine is superior to the dual combinations of valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in lowering mean sitting systolic blood pressure (MSSBP) in patients with moderate to severe hypertension. ;Secondary Objective: • To evaluate the blood pressure control rates (MSSBP/MSDBP < 140/90 mmHg) of the triple combination of valsartan/HCTZ/amlodipine in patients with moderate to severe hypertension and test the hypothesis that the percentage of patients controlled on the triple therapy is greater than the percentage of patients controlled on any of the dual therapies, valsartan/HCTZ, valsartan/amlodipine, or HCTZ/amlodipine. • To evaluate the diastolic blood pressure control rates (MSDBP < 90 mmHg) of the triple combination of valsartan/HCTZ/amlodipine in patients with moderate to severe hypertension and test the hypothesis that the percentage of patients controlled on the triple therapy is greater than the percentage of patients controlled on any of the dual therapies, valsartan/HCTZ, valsartan/amlodipine, or HCTZ/amlodipine. For detailed list of secondary objectives see full protocol;Primary end point(s): Change from baseline in MSDBP, analysed using a set of three hypothesis tests comparing the triple versus the three dual therapies. MSDBP is the average of available readings of sitting diastolic blood pressure for a given visit. Change from baseline in MSSBP, analysed using a set of three hypothesis tests comparing the triple versus the three dual therapies. MSSBP is the average of avail | — |
Countries
Greece, Portugal, Sweden, United Kingdom
Outcome results
None listed