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COMPLETED Phase 4

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

NCT00753779 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

Conditions Studied

Interventions

  • DRUG colesevelam HCl tablets, and simvastatin tablets
  • DRUG simvastatin tablets and colesevelam HCl placebo

Study Locations (14)

Florida

  • — Jacksonville
  • — Pembroke Pines
  • — St. Petersburg

Ohio

  • — Cincinnati
  • — Cleveland

Virginia

  • — Norfolk
  • — Richmond

California

  • — Los Angeles

Colorado

  • — Castle Rock

Illinois

  • — Chicago

Indiana

  • — Indianapolis

New York

  • — Rochester

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2002-11
Est. Completion 2005-04
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 NCT00753779

The ClinicalTrials.gov registry entry for NCT00753779 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 72 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 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions — of which colesevelam HCl tablets, and simvastatin 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: NCT00753779 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Florida, Ohio, Virginia. 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 NCT00753779 about?

NCT00753779 is a clinical study titled "A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.". The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

What is the current status of trial NCT00753779?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2002-11. Estimated completion is 2005-04.

What conditions does trial NCT00753779 study?

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

What interventions are being tested in trial NCT00753779?

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

Who is sponsoring clinical trial NCT00753779?

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 NCT00753779 being conducted?

This trial has 14 study locations across California, Colorado, Florida, Illinois, Indiana. 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