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Trial record 42 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT00811226
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Schering-Plough

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 pressure in patients with light to moderate hypertension, and to evaluate the percentage of patients that reach treatment goals using this antihypertensive regimen.

Condition or disease Intervention/treatment
Hypertension Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide,

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 subjects will be enrolled in Venezuela.


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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : April 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
Patients with arterial hypertension Stade I or Stade II
Drug: 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
Other Names:
  • SCH 900332
  • OLMETEC®
  • OLMETEC PLUS ®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in Venezuela with arterial hypertension Stade I or Stade II
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

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Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00811226     History of Changes
Other Study ID Numbers: P05254
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008
Keywords provided by Schering-Plough:
Hypertension Stage I
Hypertension Stage II
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists