At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 334 enrolled
Drug / intervention
Losartan (+) amlodipine +3 moredrug
Likely dose
Losartan (+) amlodipine 100 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.
The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy
In Brief
A Phase 4 clinical trial evaluating Losartan (+) amlodipine, Placebo to match losartan/amlodipine tablets, and 2 other interventions for Hypertension. Completed, enrolled 334 participants.
Detailed Summary
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartMay 2011
Primary CompletionApr 2013
TodayJul 2026
First PostedJan 17, 2011
Enrollment StartMay 30, 2011
Primary CompletionApr 22, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.5 years ago
Interventions
Losartan (+) amlodipinedrug
One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
Placebo to match losartan/amlodipine tabletsdrug
One tablet containing placebo, orally, once daily, for 8 weeks.
Amlodipine camsylatedrug
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.
Placebo to match amlodipinedrug
2 tablets containing placebo, orally, once daily, for 8 weeks.