hypertension
Conditions
Interventions
5 mg tablet authorized
two 2.5 mg tablets encapsulated for blinding (see section D1(b) on print-out)
Product Name: amlodipine
Pharmaceutical Form: Capsule*
INN or Proposed INN: amlodipine
CAS Number: 88150-42-9
Concentratio
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients = 18 years. Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed 2. Patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury sphygmomanometer. At Visit 1 (week -8 to -4), patients not treated with antihypertensive medications MUST have a MSDBP of = 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg) 2. Inability to completely discontinue all prior antihypertensive medications safely for a period of 2 to 4 weeks as required by the protocol 3. Known Keith-Wagener grade III or IV hypertensive retinopathy 4. History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit 1 (week -8 to -4) 5. Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time prior to Visit 1 (week -8 to -4) 6. Heart failure requiring treatment 7. Second or third degree heart block without a pacemaker 8. Concomitant refractory angina pectoris 9. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia 10. Clinically significant valvular heart disease 11. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease, pheochromocytoma, polycystic kidney disease, etc… 12. Diabetic patients requiring insulin treatment 13. Type 2 diabetics with poor glucose control defined as a glycosylated hemoglobin (HbA1c) > 7% at Visit 1 14. Administration of any agent indicated for the treatment of hypertension within a minimum of 2 weeks prior to enrolling into the single-blind run-in phase of the study (Visit 2, week -4), with the permitted exception of those antihypertensive medications requiring tapering down commencing at Visit 1 (week -8 to -4) 15. Known or suspected contraindications, including a history of allergy to angiotensin receptor blockers or calcium channel blockers 16. 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, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active or active inflammatory bowel syndrome within 12 months prior to Visit 1 (week -8 to -4), currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator 17. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 12 months of Visit 1 (week -8 to -4) 18. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values > 2 x ULN at Visit 1 (week -8 to -4), a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 19. Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 mg/dL for males or 1.3 mg/dL for females, a history of dialysis, or a history of nephritic syndrome 20. Sodium depletion 21. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years 22. Pregnant or breast feeding women 23. Any condition - not identified in the protocol - that in the opinion of the investigator or the Novartis monitor would jeopardize the evaluation of efficacy or safety 24. 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 the study or completing the trial period 25. History of drug or alcohol abuse within the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of the combinations of valsartan/amlodipine 160/10 or 160/5 mg, in patients with essential hypertension not adequately controlled on valsartan 160 mg monotherapy, by testing the hypothesis that either combination of valsartan/amlodipine 160/10 or 160/5 mg produces superior reduction in MSDBP from baseline to 8 weeks compared to valsartan 160 mg alone.;Secondary Objective: 1. To explore the efficacy of the combination of valsartan/amlodipine 160/10 compared to 160/5 mg, in patients with essential hypertension not adequately controlled on valsartan 160 mg monotherapy 2. To explore the efficacy of the combinations of valsartan/amlodipine 160/10 or 160/5 mg, in patients with essential hypertension not adequately controlled on valsartan 160 mg monotherapy 3. To explore the efficacy of the combination of valsartan/amlodipine 160/10 compared to 160/5 mg, in patients with essential hypertension not adequately controlled on valsartan 160 mg monotherapy 4. To explore responder rates at the end of the study; 5. To explore the safety and tolerability of these three treatments. ;Primary end point(s): Efficacy: Mean sitting systolic and diastolic blood pressure. Others: • Vital signs including mean sitting systolic and diastolic blood pressure and heart rate • Hematology, blood chemistry and pregnancy tests • Physical examination | — |
Countries
Ireland, Latvia, Lithuania, United Kingdom
Outcome results
None listed