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NCT00753779 · ClinicalTrials.gov registry record · 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.

A Phase 4 study of Hypercholesterolemia, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 4
Development phase
72
Enrollment target
14
Study locations

NCT00753779 is a Phase 4 study of Hypercholesterolemia that has completed, run by Daiichi Sankyo. The registered enrollment target is 72 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The trial reports 14 study locations across 10 states.

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The verdict

NCT00753779, a Phase 4 study of Hypercholesterolemia, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 4
Development phase
72 participants
Enrollment target
14
Study locations

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

236 total trials

What the Registry Record Tells You About NCT00753779

The ClinicalTrials.gov registry entry for NCT00753779 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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.

NCT00753779 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Florida, Ohio, Virginia.

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.

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).

Who is sponsoring clinical trial NCT00753779?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

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.

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

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