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

Hypercholesterolemia Clinical Trial

Official title:

Efficacy of WelChol as an Add-on to Pravastatin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755352
• Other study ID #: WEL-407
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: April 2, 2015
• Start date: November 2002
• Est. completion date: April 2005

Study information

• Verified date: April 2015
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2005
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• pravastatin tablets and Welchol tablets
pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
• pravastatin tablets and Welchol placebo tablets
pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.		6 weeks	No
Secondary	The absolute change in LDL-C from baseline to endpoint.		6 weeks	No
Secondary	The absolute change and % change of total cholesterol from baseline to endpoint		6 Weeks	No
Secondary	The absolute change and % change of triglycerides from baseline to endpoint		6 Weeks	No
Secondary	The absolute change and % change of HDL-C from baseline to endpoint		6 Weeks	No
Secondary	The absolute change and % change of c-reactive protein from baseline to endpoint		6 weeks	No