At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 144 enrolled
Drug / intervention
olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessarydrug
Likely dose
Not stated in 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.
National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate
In Brief
A Phase 4 clinical trial evaluating olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary for Essential Hypertension. Completed, enrolled 144 participants.
Detailed Summary
In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Hypertension
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
Primary CompletionJun 2007
Study CompletionAug 2007
First PostedApr 2009
TodayJul 2026
First PostedApr 30, 2009
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2007
Study CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.2 years ago
Interventions
olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessarydrug
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks