NCT00430950

Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,011 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets	olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
DRUG	olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-05-01
• Completion: 2008-10-01
• First posted: 2007-02-02
• Last updated: 2019-01-10
• Results posted: 2009-04-20

Locations

41 sites across 4 countries: Belgium, Germany, Netherlands, Slovakia