At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 38 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 300 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.
Effects of Direct Renin Inhibition on Atherosclerotic Biomarkers in Patients With Stable Coronary Heart Disease and Type 2 Diabetes Mellitus
In Brief
A Phase 4 clinical trial evaluating Aliskiren and Amlodipine for Coronary Artery Disease and Type 2 Diabetes Mellitus. Completed, enrolled 38 participants across 1 site.
Detailed Summary
The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Type 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2009
Primary CompletionAug 2011
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.5 years ago
Interventions
Aliskirendrug
150 - 300 mg once daily for 6 weeks
Amlodipinedrug
5-10 mg once daily for 6 weeks