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

Launched by SCHERING-PLOUGH · Dec 16, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

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