Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)

Schering-Plough450 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

450

Conditions

Hypertension

Interventions

olmesartan medoxomile alone or combined with hydrochlorothiazide,DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure

Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Secondary Outcomes

Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure

Time frame: 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®)

Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Data from ClinicalTrials.gov

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