None listed
Conditions
Interventions
Group A Type of group
Valsartan 320 mg o.d. for 12 weeks
Group name:Group C Type of group
Valsartan/HCTZ 320/25mg o.d. for 12 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory patients of both sexes from 18 to 80 years of age inclusive • With diagnosis in Visit 2 of mild to moderate hypertension with a PADMS> 95 and 95 and 90 mmHg and <110 mmHg. • Written informed consent to participate in the study before performing any study procedure • Ability to communicate and meet all the requirements of the study
Exclusion criteria
Exclusion criteria: • Severe hypertension (PADMS> 110 mmHg and / or PASMS> 180 mmHg). • Impossibility to safely discontinue all previous antihypertensive medications for a period of 2-4 weeks, as required by the protocol. • Women who have not been postmenopausal for a year or hysterectomized, or who do not use contraceptive methods recognized as the barrier method with spermicide or an intrauterine device. The use of hormonal contraceptives is not allowed. • History of hypertensive encephalopathy or cerebrovascular accident during the year preceding the visit 1. • Knowledge of Keith-Wagener hypertensive retinopathy grade III or IV. • Attack of transient cerebral ischemia, myocardial infarction, all types of revascularization procedures during the last 12 months before Visit 1. • Heart failure that requires treatment. • Second or third degree heart block without a pacemaker. • Concomitant refractory angina. • Arrhythmia with potential life risk or concurrent symptomatic arrhythmia • Clinically significant valvular heart disease. • Evidence of a secondary form of hypertension, such as coarctation of the aorta, hypoaldosteronism, unilateral or bilateral stenosis of the renal arteries, Cushing´s disease, pheochromocytoma, polycystic nephropathy, etc. • Diabetic patients who require insulin treatment • Patients with type 2 diabetes who, in the opinion of the researcher, are not adequately controlled. • Administration of any agent indicated for the treatment of hypertension after Visit 1, with the exception of antihypertensive drugs that require gradual dose reduction from Visit 1. • Knowledge or suspicion of contraindications, including a history of allergy to angiotensin antagonists or hydrochlorothiazide, or other drugs derived from sulfonamides. • Serum sodium value 5.5 mmol / L in Visit 1. • Any surgical or medical condition that could 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 band surgery, inflammatory bowel syndrome currently active or active within the 12 months prior to Visit 1, gastritis, ulcers or gastrointestinal / rectal bleeding currently active, or obstructions of the urinary tract considered clinically significant by the investigator. • Pancreatic lesion, pancreatitis or evidence of deterioration of pancreatic function / injury within the 12 months prior to Visit 1. • Evidence of liver disease determined by any of the following: SGOT or SGPT values> 2 x LSN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or antecedent portocava shunt. • Evidence of renal failure determined by any of the following: serum creatinine> 1.5 LSN at Visit 1, history of dialysis or history of nephrotic syndrome. • History of malignancy including leukemia and lymphoma (but not skin cancer a • basal cells) within the last five years • Pregnant or lactating women. • Any condition - not identified in the protocol - that in the opinion of the investigator or the Novartis medical monitor would jeopardize the efficacy or safety evaluation. • Any surgical or medical condition that, in the opinion of the investigator,
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from the baseline value in diastolic blood pressure in standing and sitting positions on visits 4 and 5 Measure:Change from the baseline value in diastolic blood pressure in standing and sitting positions on visits 4 and 5 Timepoints:Visits 4 and 5 ; Outcome name:Change from baseline in systolic blood pressure in standing and sitting position on visits 4 and 5 Measure:Change from baseline in systolic blood pressure in standing and sitting position on visits 4 and 5 Timepoints:Visits 4 and 5 | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The PADMS is defined as the average of the available readings of the diastolic blood pressure in the sitting position of a visit. Measure:Change from baseline in mean diastolic blood pressure in sitting position (PADMS) valley at the end point Timepoints:Week 16 | — |
Countries
Hungary, Peru
Outcome results
None listed