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

NCT ID: NCT00811226

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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Hypertension Stage I Hypertension Stage II

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with arterial hypertension Stade I or Stade II

olmesartan medoxomile alone or combined with hydrochlorothiazide,

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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SCH 900332 OLMETEC® OLMETEC PLUS ®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role lead

Responsible Party

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Schering-Plough

Other Identifiers

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P05254

Identifier Type: -

Identifier Source: org_study_id