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NCT00903617 · ClinicalTrials.gov registry record · Phase 2
Study to Test GSK256073 in Patients With Dyslipidemia
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00903617: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00903617 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00903617, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: \~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease overall subject numbers needed in part B. Part B of the study will include a niaspan arm for relative comparison of the effects of GSK256073 and niacin on lipids and flushing
Primary Outcome
The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.
Interventions
- DRUG Placebo
- DRUG Niaspan
- DRUG GSK256073
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-06-15 |
| Est. Completion | 2010-02-16 |
| Phase | Phase 2 |
What the finished NCT00903617 record still lists
NCT00903617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00903617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00903617 about?
NCT00903617 is a clinical study titled "Study to Test GSK256073 in Patients With Dyslipidemia". This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: \~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be a...
What is the current status of trial NCT00903617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2009-06-15. Estimated completion is 2010-02-16.
What interventions are being tested in trial NCT00903617?
The interventions under investigation include: Placebo (DRUG), Niaspan (DRUG), GSK256073 (DRUG).
Who is sponsoring clinical trial NCT00903617?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00903617's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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