Expired Study
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Jacksonville, Florida


Purpose:

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.


Criteria:

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: - 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


Study is Available At:


Original ID:

WEL-407


NCT ID:

NCT00755352


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Efficacy of WelChol as an Add-on to Pravastatin Therapy


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Daiichi Sankyo Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

67


Enrollment Type:

Actual


Study Dates

Start Date:November 2002
Completion Date:April 2005
Completion Type:Actual
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 2, 2015
First Received Date:September 16, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The absolute change and % change of c-reactive protein from baseline to endpoint
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The absolute change and % change of HDL-C from baseline to endpoint
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The absolute change and % change of triglycerides from baseline to endpoint
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The absolute change and % change of total cholesterol from baseline to endpoint
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The absolute change in LDL-C from baseline to endpoint.
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.
Time Frame:6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:pravastatin tablets and Welchol tablets
Description:pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
Arm Name:1
Intervention Type:Drug
Name:pravastatin tablets and Welchol placebo tablets
Description:pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:pravastatin tablets and Welchol placebo tablets
Study Arm Type:Experimental
Arm Name:1
Description:pravastatin tablets and Welchol tablets

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Daiichi Sankyo Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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