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NCT00491530 · ClinicalTrials.gov registry record · Phase 3

A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

A Phase 3 study, sponsored by Abbott.

Completed
Registry status
Phase 3
Development phase
310
Enrollment target

NCT00491530: Completed Phase 3 study, sponsored by Abbott.

NCT00491530 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00491530, a Phase 3 study, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 3
Development phase
310 participants
Enrollment target

Study Summary

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Primary Outcome

All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/

Interventions

  • DRUG ABT-335
  • DRUG simvastatin
  • DRUG rosuvastatin calcium
  • DRUG atorvastatin calcium

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2007-06
Est. Completion 2008-11
Phase Phase 3
Abbott

181 total trials

What the finished NCT00491530 record still lists

NCT00491530 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 4 interventions - of which ABT-335 is the first listed.

NCT00491530 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00491530 about?

NCT00491530 is a clinical study titled "A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia". The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

What is the current status of trial NCT00491530?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2007-06. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00491530?

The interventions under investigation include: ABT-335 (DRUG), simvastatin (DRUG), rosuvastatin calcium (DRUG), atorvastatin calcium (DRUG).

Who is sponsoring clinical trial NCT00491530?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00491530's enrollment target sits among peer trials

310 1107th of 2000 higher than 892 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00491530, the US trial registry maintained by the National Library of Medicine. NCT00491530 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.