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NCT00269048 · ClinicalTrials.gov registry record · Phase 2
SB-480848 In Subjects With Coronary Heart Disease
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 969
- Enrollment target
NCT00269048 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 969 participants.
The verdict
NCT00269048, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 969 participants
- Enrollment target
Study Summary
This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.
Interventions
- DRUG placebo
- DRUG SB-480848
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 969 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00269048
The ClinicalTrials.gov registry entry for NCT00269048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 969 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 placebo is the first listed.
NCT00269048 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00269048 about?
NCT00269048 is a clinical study titled "SB-480848 In Subjects With Coronary Heart Disease". This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk...
What is the current status of trial NCT00269048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 969 participants. The study started on 2005-11. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00269048?
The interventions under investigation include: placebo (DRUG), SB-480848 (DRUG).
Who is sponsoring clinical trial NCT00269048?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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