NCT00754507

Brief Summary

To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

September 16, 2008

Last Update Submit

April 2, 2015

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.

    6 weeks

Secondary Outcomes (5)

  • The absolute change in LDL-C from baseline to endpoint

    6 weeks

  • The absolute change and % change in total cholesterol

    6 Weeks

  • The absolute change and % change in triglycerides

    6 Weeks

  • The absolute change and % change in HDL-C

    6 Weeks

  • The absolute change and % change in C-reactive protein

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

colesevelam tablets and atorvastatin tablets

Drug: colesevelam HCl tablets, and atorvastatin tablets

2

PLACEBO COMPARATOR

colesevelam HCl placebo tablets and atorvastatin tablets

Drug: colesevelam HCl placebo tablets and atorvastatin tablets

Interventions

colesevelam HCl tablets, and atorvastatin tabletsDRUG

colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks

1
colesevelam HCl placebo tablets and atorvastatin tabletsDRUG

colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \> or greater than 18 years of age
  • On a stable dose of atorvastatin
  • LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
  • TG \< or = to 300 mg/dL
  • Women are not pregnant or breast-feeding or planning to become pregnant
  • Women of child-bearing potential had a hysterectomy or tubal-ligation, or
  • women were post menopausal, or
  • women practiced an acceptable method of contraception as specified in the protocol

You may not qualify if:

  • BMI \> 40 kg/m2
  • History of allergic or toxic reaction to colesevelam HCl
  • History of swallowing disorders
  • Any serious disorder that could impact the conduct of the study
  • History of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Castle Rock, Colorado, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Bartlett, Tennessee, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

November 1, 2002

Primary Completion

June 1, 2003

Study Completion

April 1, 2005

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

US(13)