Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

Hypercholesterolemia Clinical Trial

Official title:

The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754039
• Other study ID #: WEL-403
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2008
• Last updated: April 2, 2015
• Start date: February 2003
• Est. completion date: March 2004

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

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2004
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 30-70 years of age

• History of mixed hyperlipidemia

• Prescribed a Step 1 diet at least 30 days prior to screening

• Women were not pregnant, breast-feeding, or plan to become pregnant during the study

• Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures

• Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 & < 750 mg/dL

Exclusion Criteria:

• BMI >40

• HbA1C > 10%

• Type 1 diabetes

• Intolerance to fibrates

• History of intolerance to colesevelam HCl

• History of swallowing disorders or intestinal motility disorders

• Any other disorder that might interfere with the conduct of the study

• History of drug or alcohol abuse

• Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias

Intervention

Drug:
• colesevelam HCl tablets and fenofibrate tablets
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
• fenofibrate tablets and Welchol placebo tablets
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
• fenofibrate tablets and Welchol placebo tablets
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/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	% change in LDL-C from baseline		6 weeks	No
Secondary	The absolute change in LDL-C from baseline		6 weeks	No
Secondary	The absolute change and % change in LDL-C from week -8 (untreated)		14 weeks	No
Secondary	The percentage of patients who achieved target LDL-C		6 Weeks	No