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OpenTrials
Completed

NCT Number: NCT00811226

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomile alone or combined with hydrochlorothiazide,

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

Other names: SCH 900332, OLMETEC®, OLMETEC PLUS ®

Primary outcomes

  1. Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure

    Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Secondary outcomes

  1. Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure

    Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16

  2. 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®)

    Time frame: basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Sponsors and collaborators

Lead sponsor

Schering-Plough

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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