At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
LCZ696drug
Likely dose
LCZ696 400 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.
An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Mild and Moderate Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
In Brief
A Phase 1 clinical trial evaluating LCZ696 for Mild and Moderate Renal Impairment. Completed, enrolled 32 participants across 3 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild and Moderate Renal Impairment
CountriesGermany, Russia, Serbia
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedApr 2012
Primary CompletionAug 2014
TodayJul 2026
First PostedApr 3, 2012
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.2 years ago
Interventions
LCZ696drug
LCZ696 400 mg once daily