Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Schering-Plough
Treatments:
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
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