None listed
Conditions
Interventions
Group 1 Type of group
valsartan / amiodipine 160/5 mg for 2 weeks
Group name:Group 2 Type of group
Lisinopril / hydrochlorothiazide 10 / 12.5 mg for a period of 2 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Outpatient patients> 18 years old male or female. Female patients must be in the post-menopausal stage for one year or sterile by surgical methods or must be using an effective method of contraception as a barrier method with spermicide or an intra-uterine device. The use of hormonal contraceptives is not allowed. • Patients with severe hypertension should have been measured by a standard calibrated aneroid or a mercury sphygmomanometer. Patients should have a MSDBP> 95 mmHg and 110 mmHg and <120 mmHg at Visit 3.
Exclusion criteria
Exclusion criteria: • Inability to completely discontinue all previous anti-hypertensive medications in a safe manner for a period of 3 weeks required by the protocol • Knowledge of Keith-Wagener grade III or IV hypertensive retinopathy. • History of hypertensive encephalopathy or cerebrovascular accident at any time before Visit 1. • Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time before Visit 1. • Heart failure of any kind. • Second or third degree heart block with or without pacemaker • Any type of angina. • Potentially life-threatening coextensive arrhythmia or symptomatic arrhythmia • Clinically significant cardiac vascular disease. • Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, stenosis of the unilateral or bilateral renal artery, Cushing´s disease, pheochromocytoma, poikic renal disease. • Diabetic patients who require treatment with insulin. • Type 2 diabetics with poor glucose control defined by fasting glycosylated hemoglobin {Hb1Ac)> 7% at Visit 2. • Administration of any agent indicated for the treatment of hypertension with a minimum of 3 days before Inclusion within the continuous phase of single-blind study (Visit 2), with the permitted exception of that antihypertensive medication that requires to be reduced begun in Visit 1. • Knowledge or suspicion of contraindications, including history of allergy to angiotensin receptor blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors or thiazide diuretics. • Any medical or surgical condition that can 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, bypass Gastric stapling, gastric stapling or gastric anchoring, isitis 1, current active gastritis, ulcer or gastrointestinal / rectal bleeding, or obstruction of the urinary tract considered as clinically significant for the researcher. • Any history of pancreatic damage, pancreatitis or evidence of pancreatic insufficiency function / damage within 1 year of the visit 1. • Evidence of liver disease determined by any of the following tests: SGOT (AST) or SGPT (ALT) values> 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt. • Evidence of renal failure determined by any of the following: serum creatinine> 1.5 mg / dL (men) and> 1.3 mg / dL (women), a history of dialysis, or a history of nephrotic syndrome. • History of malignancy including leukemia and lymphoma (but not cancer of basal skin cells) within the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary assessment for safety and tolerability is the reporting of any serious adverse event (SAE) including death Measure:Safety profiles of the valsartan / amlodipine treatment regimen compared to the lisinopril / hydrochlorothiazide treatment regimen Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Effects on blood pressure of the valsartan / amlodipine treatment regimen compared with the treatment regimen of lisinopril / hydrochlorothiazide in patients with severe hypertension (MSDBP> 110 mmHg and 110 mmHg and 110 mmHg and 10 mmHg of baseline Timepoints:During treatment ; Outcome name:Effects on blood pressure of the valsartan / amlodipine treatment regimen compared with the treatment regimen of lisinopril / hydrochlorothiazide in patients with severe hypertension (MSDBP> 110 mmHg and 110 mmHg and <120 mmHg). Measure:Changes of the basal foot pressure in diastolic, Changes in the basal foot systolic pressure, Changes in the basal rate of the sitting pulse, Changes in the baseline of the standing pulse Timepoints:During treatment | — |
Countries
United States
Outcome results
None listed