NCT00751751

Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil + hydrochlorothiazide, if necessary	oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
DRUG	losartan + hydrochlorothiazide, if necessary	oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-04-01
• Completion: 2005-06-01
• First posted: 2008-09-12
• Last updated: 2008-09-12

Locations

1 site across 1 country: Germany