Status:
COMPLETED
Assessment of the Effectiveness of OLMETEC® and OLMETEC PLUS® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
Lead Sponsor:
Schering-Plough
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
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 pressur...
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00811226
Start Date
April 1 2007
End Date
January 1 2008
Last Update
December 18 2008
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