Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00811226
- Lead Sponsor
- Schering-Plough
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients olmesartan medoxomile alone or combined with hydrochlorothiazide, Patients with arterial hypertension Stade I or Stade II
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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