At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 165 enrolled
Drug / intervention
Amlodipine 2.5mg/Atorvastatin 5mg +3 moredrug
Likely dose
Amlodipine 2.5mg/Atorvastatin 5mgfrom 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 Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 18, 2007·Updated Jan 28, 2021
In Brief
A Phase 3 clinical trial evaluating Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg, and 2 other interventions for Hypertension and Hypercholesterolemia. Completed, enrolled 165 participants across 17 sites.
Detailed Summary
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Hypercholesterolemia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionApr 2008
TodayJul 2026
First PostedSep 18, 2007
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.8 years ago
Interventions
Amlodipine 2.5mg/Atorvastatin 5mgdrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 2.5mg/Atorvastatin 10mgdrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 5mgdrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 10mgdrug
Single pill combination, dosed once daily for 8 weeks