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CompletedNCT00755352Updated Apr 3, 2015

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

A Phase 4 interventional study of pravastatin tablets and Welchol tablets and pravastatin tablets and Welchol placebo tablets in Hypercholesterolemia, sponsored by Daiichi Sankyo. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-03.

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

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.

02

Conditions studied

  • Hypercholesterolemia
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 67 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female > or = to 18 years of age
  • On a stable dose of pravastatin
  • LDL-C > or = to 100 mg/dL and \< or = 250 mg/dL
  • Triglycerides \< or = to 300 mg/dL
  • Women are not pregnant or breast-feeding or planning to become pregnant
  • Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion criteria

Exclusion Criteria:

  • BMI > 40 kg/m2
  • History of allergic or toxic reaction to colesevelam HCL
  • History of swallowing disorder
  • Any serious condition that would interfere with the conduct of the study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    1

    pravastatin tablets and Welchol tablets

    Drug: pravastatin tablets and Welchol tablets

  • Placebo comparator
    2

    pravastatin tablets and Welchol placebo tablets

    Drug: pravastatin tablets and Welchol placebo tablets

Interventions

  • Drugpravastatin tablets and Welchol tablets

    pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks

  • Drugpravastatin tablets and Welchol placebo tablets

    pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day

06

What researchers measure

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

  2. The absolute change and % change of total cholesterol from baseline to endpoint

    Time frame: 6 Weeks

  3. The absolute change and % change of triglycerides from baseline to endpoint

    Time frame: 6 Weeks

  4. The absolute change and % change of HDL-C from baseline to endpoint

    Time frame: 6 Weeks

  5. The absolute change and % change of c-reactive protein from baseline to endpoint

    Time frame: 6 weeks

07

Study locations

15 sites
  • Los Angeles, California, United States
  • Castle Rock, Colorado, United States
  • Jacksonville, Florida, United States
  • Pembroke Pines, Florida, United States
  • St. Petersburg, Florida, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Rochester, New York, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Bartlett, Tennessee, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00755352
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Sep 18, 2008
Start date
Nov 2002
Primary completion
Jun 2003
Completion
Apr 2005
Last update
Apr 3, 2015

Oversight

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

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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