Hypertension
Conditions
Keywords
Hypertension Stage I, Hypertension Stage II
Brief summary
The purpose of this study is to determine the efficiency of Olmesartan medoxomile (OLMETEC®) alone or in combination with hydrochlorothiazide (OLMETEC PLUS®) in the reduction of arterial blood pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.
Detailed description
α= 0.05. α's Z=1.96 β= 80%. β's Z=0.84 Estimated proportion of subjects to achieve optimal control of arterial hypertension= 83.2% 450 subjects are expected to be enrolled in the study of which 40 subjects will be enrolled in Venezuela.
Interventions
DRUGolmesartan medoxomile alone or combined with hydrochlorothiazide,
olmesartan medoxomile 20mg/daily or 40mg/daily; olmesartan medoxomile 20mg plus 12.5 mg of hydrochlorothiazide daily; olmesartan medoxomile 40mg plus 12.5 mg of hydrochlorothiazide daily
Sponsors
Schering-Plough
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women 18 years of age or older * Essential arterial hypertension Stade I and II according to JNC VII * Signature of Informed Consent
Exclusion criteria
* Secondary arterial hypertension * Pregnant woman or during lactancy * Recent cardiovascular disease, as heart attack, unstable angina, or procedures of coronary revascularization on the previous six months. * Acute Coronary Failure Syndrome on the previous six months. * Chronic Ischemic Cardiopathy Treatment. * Cerebral Vascular Disease on the previous six months. * Alcoholism Story or use of drugs on the two previous years. * Hepatic Disease Story * Chronic Renal Failure defined by a serumal creatinine higher than 2mg/dl * Albuminuria higher than 1gr. * Known Allergy to blockers of angiotensine II receptors. * Neoplasmic Malignant Disease included leukemia and the lymphoma (Skin basocellular cancer is not included) * Auto Immune Disorders as systemic erythematosus lupus. * Non attachment to medical treatments history. * Patients sharing some clinical investigation essay on the last 3 months. * Congestive heart failure under previous treatment with ECA inhibitors. * Allergy to thiazidic diuretics. * Angioedema History * Use of drugs that affect potassium secretion, as diuretic savers of potassium, angiotensine enzyme inhibitor, betablockers, non-steroid anti-inflammatory drugs. * Potassium consumption orally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure | basal registry and on follow-up visits in weeks 4, 8, 12, and 16 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure | basal registry and on follow-up visits in weeks 4, 8, 12, and 16 |
| Evaluation of the percentage of patients (including diabetics and those with renal disease) that achieve arterial blood pressure treatment goals with Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) | basal registry and on follow-up visits in weeks 4, 8, 12, and 16 |
Outcome results
None listed