Official Title: “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”

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: olmesartan 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

Arms, Groups and Cohorts in this Clinical Trial

• : Patients
  • Patients with arterial hypertension Stade I or Stade II

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00811226

Study ID Number: P05254

ClinicalTrials.gov Identifier: NCT00811226

Health Authority: Venezuela: Instituto Nacional De Higiene "Rafael Rangel"