Clinical trial NCT00811226: Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension Stage I
Hypertension Stage II
Lead sponsor: Schering-Plough
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Venezuela with arterial hypertension Stade I or Stade 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure
timeFrame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Secondary outcomes:
measure: Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure
timeFrame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
measure: 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®)
timeFrame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16
Other outcomes:
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