Prospective, Multicentric, Open Clinic Essay to Evaluate the Use of OLMETEC® (Olmesartan Medoxomile) and OLMETEC PLUS® (Olmesartan Medoxomile Hydrochlorothiazide) in Stade I and II, According to JNC VII
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 主要终点
- Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 years of age or older
- •Essential arterial hypertension Stade I and II according to JNC VII
- •Signature of Informed Consent
排除标准
- •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
研究组 & 干预措施
Patients
Patients with arterial hypertension Stade I or Stade II
干预措施: olmesartan medoxomile alone or combined with hydrochlorothiazide, (Drug)
结局指标
主要结局
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure
时间窗: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
次要结局
- 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)