At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
LCZ696A +1 moredrug
Likely dose
LCZ696A 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 Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
In Brief
A Phase 2 clinical trial evaluating LCZ696A for Pharmacokinetics and 2 related conditions. Completed, enrolled 12 participants across 3 sites in 3 countries.
Detailed Summary
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Renal Impaired, Healthy Volunteer
CountriesGermany, Russia, Serbia
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
Primary CompletionSep 2009
First PostedApr 2012
TodayJul 2026
First PostedApr 3, 2012
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.2 years ago
Interventions
LCZ696Adrug
LCZ696Adrug
once daily administration of 400 mg LCZ696 for 5 days