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

NCT00811226 | Completed

• 1 other identifier: P05254
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Hypertension Stage I; Hypertension Stage II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Patients

Patients with arterial hypertension Stade I or Stade II

Drug: olmesartan medoxomile alone or combined with hydrochlorothiazide,

Interventions

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

Also known as: SCH 900332, OLMETEC®, OLMETEC PLUS ®

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Venezuela with arterial hypertension Stade I or Stade II

You may qualify if:

• Men or women 18 years of age or older
• Essential arterial hypertension Stade I and II according to JNC VII
• Signature of Informed Consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schering-Plough: lead

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: December 18, 2008
• Study Start: April 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12