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COMPLETED Phase 4

Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

NCT00754039 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Interventions

  • DRUG colesevelam HCl tablets and fenofibrate tablets
  • DRUG fenofibrate tablets and Welchol placebo tablets

Study Locations (10)

Florida

  • — Longwood
  • — Ocala
  • — Winterpark

Illinois

  • — Chicago
  • — Lombard

Kansas

  • — Overland Park

North Carolina

  • — Stateville

Ohio

  • — Cincinnati

Texas

  • — San Antonio

Virginia

  • — Richmond

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2003-02
Est. Completion 2004-03
Phase Phase 4

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00754039

The ClinicalTrials.gov registry entry for NCT00754039 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions — of which colesevelam HCl tablets and fenofibrate tablets is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00754039 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Florida, Illinois, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00754039 about?

NCT00754039 is a clinical study titled "Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol". The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

What is the current status of trial NCT00754039?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2003-02. Estimated completion is 2004-03.

What conditions does trial NCT00754039 study?

This clinical trial studies the following conditions: Hypercholesterolemia, Hyperlipidemia, Familial Combined. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00754039?

The interventions under investigation include: colesevelam HCl tablets and fenofibrate tablets (DRUG), fenofibrate tablets and Welchol placebo tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00754039?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00754039 being conducted?

This trial has 10 study locations across Florida, Illinois, Kansas, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial