NCT00811226

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Schering-Plough · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2008-12-18
• Last updated: 2008-12-18