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NCT01852565 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01852565 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants.
The verdict
NCT01852565, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient populations with chronic coronary heart disease and after an acute coronary syndrome. This study will determine the effect of repeated administration of diltiazem on the pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.
Interventions
- DRUG Diltiazem
- DRUG Darapladib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-05-14 |
| Est. Completion | 2013-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01852565
The ClinicalTrials.gov registry entry for NCT01852565 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diltiazem is the first listed.
NCT01852565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01852565 about?
NCT01852565 is a clinical study titled "Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).". Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient population...
What is the current status of trial NCT01852565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-05-14. Estimated completion is 2013-09-30.
What interventions are being tested in trial NCT01852565?
The interventions under investigation include: Diltiazem (DRUG), Darapladib (DRUG).
Who is sponsoring clinical trial NCT01852565?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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