CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,689 enrolled
Drug / intervention
olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo +7 moredrug
Likely dose
olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo 20 mgfrom 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/NCT00923091
NCT00923091Phase 3Completed

Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension

Daiichi Sankyo·interventional·Posted Jun 18, 2009·Updated Jan 10, 2019

In Brief

A Phase 3 clinical trial evaluating olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo, Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo, and 2 other interventions for Essential Hypertension. Completed, enrolled 2,689 participants across 133 sites in 15 countries.

Detailed Summary

This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Czechia, Denmark, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.0 years ago

Interventions

olmesartan medoxomil + amlodipine + hydroclororthiazide + placebodrug

One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebodrug

One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

olmesartan medoxomil + amlodipine + hydroclororthiazidedrug

One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.

olmesartan medoxomil + amlodipine + hydroclororthiazidedrug

One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.

olmesartan medoxomil + amlodipine + hydroclororthiazidedrug

One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.

olmesartan medoxomil + amlodipinedrug

One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day

olmesartan medoxomil + amlodipinedrug

One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.

olmesartan medoxomil + amlodipinedrug

One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.