NCT00311155

Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 694 (actual)
• Sponsor: Sankyo Pharma Gmbh · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-04-05
• Last updated: 2010-12-10
• Results posted: 2010-11-10

Locations

79 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom