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NCT00616772 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
A Phase 3 study of Coronary Artery Disease and Dyslipidemia, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 3
- Development phase
- 682
- Enrollment target
- 20
- Study locations
NCT00616772: Completed Phase 3 study of Coronary Artery Disease and Dyslipidemia, sponsored by AbbVie (prior sponsor, Abbott).
NCT00616772 is a Phase 3 study of Coronary Artery Disease and Dyslipidemia that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 682 participants, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616772, a Phase 3 study of Coronary Artery Disease and Dyslipidemia, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 682 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.
Primary Outcome
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements wi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ABT-335
- OTHER Atorvastatin
Study Locations (20)
California
- Site Reference ID/Investigator# 25082 - Anaheim
- Site Reference ID/Investigator# 21347 - Corona
- Site Reference ID/Investigator# 21483 - Garden Grove
- Site Reference ID/Investigator# 21351 - Huntington Beach
- Site Reference ID/Investigator# 21346 - Laguna Hills
- Site Reference ID/Investigator# 21341 - Long Beach
- Site Reference ID/Investigator# 21342 - Norwalk
- Site Reference ID/Investigator# 21321 - Santa Ana
- Site Reference ID/Investigator# 26242 - Tustin
Arizona
- Site Reference ID/Investigator# 6747 - Chandler
- Site Reference ID/Investigator# 7089 - Gilbert
- Site Reference ID/Investigator# 7097 - Mesa
- Site Reference ID/Investigator# 26394 - Phoenix
- Site Reference ID/Investigator# 6848 - Scottsdale
- Site Reference ID/Investigator# 7059 - Tempe
- Site Reference ID/Investigator# 7094 - Tempe
- Site Reference ID/Investigator# 7098 - Tempe
Colorado
- Site Reference ID/Investigator# 15283 - Arvada
- Site Reference ID/Investigator# 7085 - Aurora
- Site Reference ID/Investigator# 6749 - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT00616772 record still lists
NCT00616772 is an interventional study that assigns participants to a tested intervention. The registered 682 participants enrollment target is mid-sized for trials with a published cap, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (47% lower).
The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00616772 names 20 study sites across 3 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT00616772 about?
NCT00616772 is a clinical study titled "Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood". The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after ...
What is the current status of trial NCT00616772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 682 participants. The study started on 2008-02. Estimated completion is 2012-09.
What conditions does trial NCT00616772 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Dyslipidemia, Coronary Heart Disease.
What interventions are being tested in trial NCT00616772?
The interventions under investigation include: Placebo (DRUG), ABT-335 (DRUG), Atorvastatin (OTHER).
Who is sponsoring clinical trial NCT00616772?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00616772 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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682 65th of 219 higher than 155 of 219 other Coronary Artery Disease trials
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