At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 207 enrolled
Drug / intervention
Amlodipine +2 moredrug
Likely dose
Amlodipine 5 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.
A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects
In Brief
A Phase 4 clinical trial evaluating Amlodipine, amlodipine / olmesartan medoxomil combination, and 1 other intervention for Type 2 Diabetes and Hypertension. Completed, enrolled 207 participants across 21 sites.
Detailed Summary
To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartMay 2008
Primary CompletionApr 2009
Study CompletionJun 2009
TodayJul 2026
First PostedApr 9, 2008
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.2 years ago
Interventions
Amlodipinedrug
Amlodipine 5 mg tablets , Daily for 3 weeks;
amlodipine / olmesartan medoxomil combinationdrug
amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
Hydrochlorothiazidedrug
hydrochlorothiazide tablets, 12.5 mg or 25 mg.