CClinicalTrials.gg
CompletedNCT00185107Updated Sep 11, 2007

Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

A Phase 4 interventional study of Colesevelam Hydrochloride and Ezetimibe in Hypercholesterolemia, sponsored by Daiichi Sankyo. Completed at 7 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-09-11.

Sponsored by Daiichi Sankyo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • Safety
  • Efficacy
  • WelChol®
  • Zocor®
  • Zetia®
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 45 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-80 years of age, inclusive;
  • A history of primary hypercholesterolemia

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
45 participants

Interventions

  • DrugColesevelam Hydrochloride
  • DrugEzetimibe
  • DrugSimvastatin
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. - The absolute change in LDL-C from baseline

  2. - The percent change in LDL-C from baseline

  3. - The absolute changes and percent changes in TG, non-HDL-

  4. C, HDL-C, total cholesterol and other lipid measures

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

07

Study locations

7 sites
  • Scripps Clinic
    San Diego, California 92128, United States
  • Renstar Medical Research
    Ocala, Florida 34471, United States
  • Radiant Research
    Overland Park, Kansas 66215, United States
  • L-MARC Research Center
    Louisville, Kentucky 40213, United States
  • Radiant Research
    Edina, Minnesota 55435, United States
  • Medical Office
    Statesville, North Carolina 28677, United States
  • Linder Clinical Trial Center
    Cincinnati, Ohio 45219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00185107
Lead sponsor
Daiichi Sankyo
First posted
Sep 16, 2005
Start date
Mar 2005
Completion
Oct 2005
Last update
Sep 11, 2007

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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