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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 80 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00903617
The ClinicalTrials.gov registry entry for NCT00903617 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 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 3 interventions - of which Placebo is the first listed.
NCT00903617 reports 0 study locations.
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.
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