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

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: pravastatin tablets and Welchol placebo tablets; Drug: pravastatin tablets and Welchol tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00755352

WEL-407

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

pravastatin tablets and Welchol tablets

Treatment:

Drug: pravastatin tablets and Welchol tablets

2

Placebo Comparator group

Description:

pravastatin tablets and Welchol placebo tablets

Treatment:

Drug: pravastatin tablets and Welchol placebo tablets