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NCT00728910 · ClinicalTrials.gov registry record · Phase 2

Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study

A Phase 2 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT00728910: Completed Phase 2 study, sponsored by University of Pennsylvania.

NCT00728910 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00728910, a Phase 2 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and hopefully reduce risk of heart disease. The combination therapy will include Lipitor, Niaspan, and investigational medication (known as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three medications together might improve risk factors for atherosclerosis and influence HDL cholesterol. The study will also look at the safety and any side effects that might be associated with this combination of medications.

Primary Outcome

After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a

Interventions

  • DRUG Atorvastatin
  • DRUG ABT335
  • DRUG ER Niacin

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-06
Est. Completion 2009-08
Phase Phase 2
University of Pennsylvania

1,423 total trials

What the finished NCT00728910 record still lists

NCT00728910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 3 interventions - of which Atorvastatin is the first listed.

NCT00728910 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00728910 about?

NCT00728910 is a clinical study titled "Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study". The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to impr...

What is the current status of trial NCT00728910?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2008-06. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00728910?

The interventions under investigation include: Atorvastatin (DRUG), ABT335 (DRUG), ER Niacin (DRUG).

Who is sponsoring clinical trial NCT00728910?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00728910's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 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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Source: ClinicalTrials.gov NCT00728910, the US trial registry maintained by the National Library of Medicine. NCT00728910 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.