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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in Venezuela with arterial hypertension Stade I or Stade II

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing diastolic pressure	basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the efficiency of Olmesartan medoxomile (OLMETEC®) alone, or in combination with hydrochlorothiazide (OLMETEC PLUS®) in decreasing systolic pressure	basal registry and on follow-up visits in weeks 4, 8, 12, and 16
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®)	basal registry and on follow-up visits in weeks 4, 8, 12, and 16

Collaborators and Investigators

• Sponsor: Schering-Plough

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): December 18, 2008
• Last Update Submitted That Met QC Criteria: December 16, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Hypertension Stage I; Hypertension Stage II
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide
• Other Study ID Numbers: P05254