NCT00185107

Brief Summary

Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

7 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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

September 9, 2005

Last Update Submit

September 10, 2007

Conditions

Hypercholesterolemia

Keywords

SafetyEfficacyWelChol®Zocor®Zetia®

Outcome Measures

Primary Outcomes (1)

  • The percent change in LDL-C from the start of the study

Secondary Outcomes (5)

  • - The absolute change in LDL-C from baseline

  • - The percent change in LDL-C from baseline

  • - The absolute changes and percent changes in TG, non-HDL-

  • C, HDL-C, total cholesterol and other lipid measures

  • - The percentages of patients who achieve target levels of LDL-C at the end of the study

Interventions

Colesevelam HydrochlorideDRUG
EzetimibeDRUG
SimvastatinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, inclusive;
  • A history of primary hypercholesterolemia

You may not qualify if:

  • Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
  • Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Scripps Clinic

San Diego, California, 92128, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Radiant Research

Overland Park, Kansas, 66215, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Radiant Research

Edina, Minnesota, 55435, United States

Location

Medical Office

Statesville, North Carolina, 28677, United States

Location

Linder Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Colesevelam HydrochlorideEzetimibeSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2005

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

US(7)