Hypertension
Conditions
Interventions
Product Name: Valsartan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Valsartan
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration number: 160-
Pharmaceutical form of
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients = 18 years of age. 2. Patients with stage II hypertension defined as MSSBP = 160 mmHg and MSSBP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics or to drugs with similar chemical structures. 2. Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 21 days prior to Visit 2, as required by the protocol. 3. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down. 4. MSSBP = 200 mmHg and/or MSDBP > 120 mmHg at any time during the study. 5. Patients with controlled hypertension (MSSBP 2 x UNL at Visit 1, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt. 22. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 12 months of Visit 1. 23. Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x UNL at visit 1, history of dialysis, or history of nephrotic syndrome. 24. Serum sodium value < 132 mmol/L at Visit 1. 25. Serum potassium values < 3.2 mmol/L at Visit 1. 26. Any surgical or medical condition which might 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 i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superior efficacy of the combination of valsartan/amlodipine 160/10 mg in patients with stage II hypertension, by testing the hypothesis that the valsartan/amlodipine 160/10 mg combination regimen produces a superior reduction in MSSBP from baseline compared to amlodipine 10 mg monotherapy at week 4.;Secondary Objective: 1. To compare the valsartan/amlodipine treatment regimen with the amlodipine treatment regimen in change from baseline MSSBP after 2 and 8 weeks of treatment. 2. To compare the valsartan/amlodipine treatment regimen with the amlodipine treatment regimen in change from baseline MSDBP after 2, 4 and 8 weeks of treatment. 3. To compare the valsartan/amlodipine treatment regimen with the amlodipine treatment regimen in the proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment. 4. To evaluate the safety and tolerability of the valsartan/amlodipine and amlodipine treatment regimens. ;Primary end point(s): The primary efficacy variable is change from baseline in mean sitting systolic blood pressure (MSSBP) at Endpoint (Week 4). | — |
Countries
Belgium, Italy, Spain, United Kingdom
Outcome results
None listed