CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,204 enrolled
Drug / intervention
Olmesartan medoxomil 40 mg - Amlodipine 10 mg +5 moredrug
Likely dose
Olmesartan medoxomil 40 mg - Amlodipine 10 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/NCT00902538
NCT00902538Phase 3Completed
CompareCT.gov

Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone

Daiichi Sankyo·interventional·Posted May 15, 2009·Updated Jan 11, 2019

In Brief

A Phase 3 clinical trial evaluating Olmesartan medoxomil 40 mg - Amlodipine 10 mg, Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg, and 3 other interventions for Essential Hypertension. Completed, enrolled 2,204 participants across 117 sites in 14 countries.

Detailed Summary

Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows: Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
CountriesAustria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2009
Enrollment StartApr 1, 2009
Primary CompletionSep 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.1 years ago

Interventions

Olmesartan medoxomil 40 mg - Amlodipine 10 mgdrug

Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily

Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mgdrug

Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.

Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mgdrug

Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day.

OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgdrug

Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.

OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mgdrug

Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.

OLM 40mg-AML 10mg-Hydrochlorothiazide 25mgdrug

Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day.