NCT00430508

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 972 (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 and placebo	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
DRUG	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
DRUG	olmesartan medoxomil/hydrochlorothiazide tablets	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
DRUG	olmesartan medoxomil/hydrochlorothiazide tablets	olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2008-05-01
• First posted: 2007-02-02
• Last updated: 2019-01-09
• Results posted: 2009-06-17

Locations

55 sites across 7 countries: Bulgaria, Czechia, France, Germany, Poland, Spain, Ukraine