At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
ISIS-APO(a)Rx +1 moredrug
Likely dose
ISIS-APO(a)Rx 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.
A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients With High Lipoprotein(a)
In Brief
A Phase 2 clinical trial evaluating ISIS-APO(a)Rx and Placebo for Elevated Lipoprotein(a). Completed, enrolled 64 participants across 13 sites in 5 countries.
Detailed Summary
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElevated Lipoprotein(a)
CountriesCanada, Denmark, Germany, Netherlands, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJun 2014
Primary CompletionNov 2015
TodayJul 2026
First PostedJun 11, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.1 years ago
Interventions
ISIS-APO(a)Rxdrug
ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
Placebodrug
Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.