CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 972 enrolled
Drug / intervention
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo +3 moredrug
Likely dose
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00430508
NCT00430508Phase 3Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Feb 2, 2007·Updated Jan 9, 2019

In Brief

A Phase 3 clinical trial evaluating olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo, olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets, and 1 other intervention for Essential Hypertension. Completed, enrolled 972 participants across 55 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesBulgaria, Czechia, France, Germany, Poland, Spain, Ukraine
CollaboratorsDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.4 years ago

Interventions

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebodrug

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tabletsdrug

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil/hydrochlorothiazide tabletsdrug

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

olmesartan medoxomil/hydrochlorothiazide tabletsdrug

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks